(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.
[63 FR 59718, Nov. 5, 1998]