21 C.F.R. § 880.2700

Current through September 30, 2024
Section 880.2700 - Stand-on patient scale
(a)Identification. A stand-on patient scale is a device intended for medical purposes that is used to weigh a patient who is able to stand on the scale platform.
(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 the limitations in § 880.9 . The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 , with respect to general requirements concerning records, and § 820.198 , with respect to complaint files.

21 C.F.R. §880.2700

45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38803, July 25, 2001