GroundRules
21 CFR 880.6710: Medical ultraviolet water purifier.
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 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
- Subpart G—General Hospital and Personal Use Miscellaneous Devices
(a) Identification. A medical ultraviolet water purifier is a device intended for medical purposes that is used to destroy bacteria in water by exposure to ultraviolet radiation.
(b) Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 880.9.
Collected 2026-08-27T02:24:47Z. Source file · JSON