21 C.F.R. § 880.2930

Current through November 30, 2024
Section 880.2930 - Apgar timer
(a)Identification. The Apgar timer is a device intended to alert a health care provider to take the Apgar score of a newborn infant.
(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 is also exempt from the current good manufacturing practice requirements in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.

21 C.F.R. §880.2930

63 FR 59718, Nov. 5, 1998