21 CFR Chapter I Subchapter H – Medical Devices – Part 868 Anesthesiology Devices

Name: 21 CFR Chapter I Subchapter H – Medical Devices – Part 868 Anesthesiology Devices
Creator: Food and Drug Administration
Keywords: 21-cfr,510k,accessories,anesthesiology,approval,beds,blood,calibrators,catheters,cosmetics,dental,diagnostics,drugs,emergency,exemptions,fixation,hydrogen,kits,medical-devices,monitoring,nasal,needles,nitrogen,nose,patients,peripheral,pre-market,pre-market-approval,provisions,regulations,requirements,sampling,stimulators,support,tables,treatment,ultrasonic,ventilators

Information

Original link

Type

Regulation

Regulated products

Medical Devices

Last updated

May 21, 2024

Description

This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 868 Anesthesiology Devices".

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

Feedback

Suggest an improvement to this page

5 Main files

Subpart A – General Provisions

Updated on January 5, 2017

html

URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-868/subpart-A
Permalink: https://data.openrid.co/en/datasets/r/02154e24-464b-4442-90aa-a8bd268d4d91
MIME Type: text/html

Created on: February 6, 2024
Modified on: January 5, 2017

Scope. Effective dates of requirement for premarket approval. Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B – Diagnostic Devices

Updated on May 21, 2024

html

URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-868/subpart-B
Permalink: https://data.openrid.co/en/datasets/r/943fdcf7-da01-4b9f-bda5-02f2b535b661
MIME Type: text/html

Created on: February 6, 2024
Modified on: May 21, 2024

Manual algesimeter. Powered algesimeter. Argon gas analyzer. Arterial blood sampling kit. Indwelling blood oxyhemoglobin concentration analyzer. Indwelling blood carbon dioxide partial pressure (P_2CO2) analyzer. Indwelling blood hydrogen ion concentration (pH) analyzer. Indwelling blood oxygen partial pressure (P_O2) analyzer. Carbon dioxide gas analyzer. Carbon monoxide gas analyzer. Enflurane gas analyzer. Ventilatory electrical impedance tomograph. Gas collection vessel. Halothane gas analyzer. Helium gas analyzer. Neon gas analyzer. Nitrogen gas analyzer. Nitrous oxide gas analyzer. Oxygen gas analyzer. Oxygen uptake computer. Pressure plethysmograph. Volume plethysmograph. Inspiratory airway pressure meter. Rhinoanemometer. Diagnostic spirometer. Monitoring spirometer. Peak-flow meter for spirometry. Gas volume calibrator. Pulmonary-function data calculator. Predictive pulmonary-function value calculator. Diagnostic pulmonary-function interpretation calculator. Esophageal stethoscope. Esophageal stethoscope with electrical conductors. Stethoscope head. Switching valve (ploss). Water vapor analyzer.

Subpart C – Monitoring Devices

Updated on January 1, 2020

html

URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-868/subpart-C
Permalink: https://data.openrid.co/en/datasets/r/2c6e26a1-69a9-4181-972f-bd67e9861ea8
MIME Type: text/html

Created on: February 6, 2024
Modified on: January 1, 2020

Ultrasonic air embolism monitor. Bourdon gauge flowmeter. Uncompensated thorpe tube flowmeter. Compensated thorpe tube flowmeter. Gas calibration flowmeter. Breathing frequency monitor. Apnea monitor. Nitric oxide analyzer. Nitrogen dioxide analyzer. Lung water monitor. Cutaneous carbon dioxide (PcCO2) monitor. Cutaneous oxygen (PcO2) monitor. Pneumotachometer. Airway pressure monitor. Gas pressure gauge. Gas pressure calibrator. Pressure regulator. Electrical peripheral nerve stimulator. Differential pressure transducer. Gas flow transducer. Gas pressure transducer.

Subpart F – Therapeutic Devices

Updated on March 31, 2023

html

URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-868/subpart-F
Permalink: https://data.openrid.co/en/datasets/r/17cc92b9-e711-4514-863b-e3289431a116
MIME Type: text/html

Created on: February 6, 2024
Modified on: March 31, 2023

Emergency airway needle. Retrograde intubation device. Nasopharyngeal airway. External negative pressure airway aid. Oropharyngeal airway. Device to relieve acute upper airway obstruction. Anesthesia conduction catheter. Anesthesia conduction filter. Anesthesia conduction kit. Anesthesia conduction needle. Gas machine for anesthesia or analgesia. Nitric oxide administration apparatus. Laryngotracheal topical anesthesia applicator. Rocking bed. Blow bottle. Anesthesia breathing circuit. Breathing circuit circulator. Breathing circuit bacterial filter. Breathing system heater. Positive airway pressure delivery system. Breathing tube support. Carbon dioxide absorbent. Carbon dioxide absorber. Reservoir bag. Breathing gas mixer. Nasal oxygen cannula. Nasal oxygen catheter. Posture chair for cardiac or pulmonary treatment. Heat and moisture condenser (artificial nose). Electroanesthesia apparatus. Ether hook. Gas-scavenging apparatus. Portable oxygen generator. Respiratory gas humidifier. High flow humidified oxygen delivery device. Therapeutic humidifier for home use. Hyperbaric chamber. Isocapnic ventilation device. Flexible laryngoscope. Rigid laryngoscope. Anesthetic gas mask. Gas mask head strap. Nonrebreathing mask. Oxygen mask. Scavenging mask. Venturi mask. Breathing mouthpiece. Nebulizer. Medicinal nonventilatory nebulizer (atomizer). Esophageal obturator. Portable liquid oxygen unit. Powered percussor. Rebreathing device. Incentive spirometer. Nonpowered oxygen tent. Electrically powered oxygen tent. Bronchial tube. Tracheal tube. Tracheal/bronchial differential ventilation tube. Inflatable tracheal tube cuff. Cuff spreader. Tracheal tube fixation device. Tube introduction forceps. Tracheal tube stylet. Tracheal tube cleaning brush. Tracheostomy tube and tube cuff. Airway connector. Dental protector. Autotransfusion apparatus. Pressure tubing and accessories. Nonrebreathing valve. Anesthetic vaporizer. Continuous ventilator. Noncontinuous ventilator (IPPB). Manual emergency ventilator. Powered emergency ventilator. External negative pressure ventilator. Intermittent mandatory ventilation attachment. Positive end expiratory pressure breathing attachment. Ventilator tubing. Tee drain (water trap).

Subpart G – Miscellaneous

Updated on January 1, 2020

html

URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-868/subpart-G
Permalink: https://data.openrid.co/en/datasets/r/c6f83f72-5cd4-4134-be91-6f39f750c255
MIME Type: text/html

Created on: February 6, 2024
Modified on: January 1, 2020

Anesthetic cabinet, table, or tray. Cardiopulmonary emergency cart. Nose clip. Portable air compressor. Calibration gas. Anesthesia stool. Tracheobronchial suction catheter. Patient position support. Medical gas yoke assembly.

21 CFR Chapter I Subchapter H – Medical Devices – Part 868 Anesthesiology Devices

Information

Type

Regulated products

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

Actions

Social networks

Embed