Cardiovascular, Orthopedic, and Physical Medicine Diagnostic Devices; Reclassification of Cardiopulmonary Bypass Accessory Equipment, Goniometer Device, and Electrode Cable Devices
Information
Type
Rule
Regulated products
Published
April 11, 2000
Last updated
April 11, 2000
Description
Document number 00-8850. The Food and Drug Administration (FDA) is reclassifying from class I into class II the cardiopulmonary bypass accessory equipment device that involves an electrical connection to the patient, the goniometer device, and the electrode cable. FDA is also exempting these devices from the premarket notification requirements. FDA is reclassifying these devices on its own initiative based on new information. FDA is taking this action to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)