§880.6710. Medical ultraviolet water purifier.
21 C.F.R. § 880.6710
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.
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.
Notes, amendments, and revision history
Amendments
[45 FR 69682, Oct. 21, 1980, as amended at 83 FR 25915, June 5, 2018]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.
Amendments
[45 FR 69682, Oct. 21, 1980, as amended at 83 FR 25915, June 5, 2018]