GroundRules
21 CFR 878.4960: Operating tables and accessories and operating chairs and accessories.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 878—GENERAL AND PLASTIC SURGERY DEVICES
- Subpart E—Surgical Devices
(a) Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Collected 2026-08-27T02:24:47Z. Source file · JSON