Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities

Name: Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities
Creator: Food and Drug Administration
Keywords: 510k,endoscope,guidances,health-care-facilities,notification,pre-market,pre-market-notification,submissions,washers

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

August 1, 1993

Last updated

March 17, 2020

Description

This document provides guidance on premarket notification submissions for automated endoscope washers, washer/disinfectors, and disinfectors in healthcare facilities.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

Feedback

Suggest an improvement to this page

1 Main file

Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities

Updated on March 17, 2020

pdf (954.9KB)

URL: https://www.fda.gov/media/72345/download
Permalink: https://data.openrid.co/en/datasets/r/8a7b0e3e-d53c-4fb5-9a31-988cc7001968
MIME Type: application/pdf

Created on: August 1, 1993
Modified on: March 17, 2020

Size: 954.9KB

Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities

Information

Type

Regulated products

Topics

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

Actions

Social networks

Embed