---
kind: "section"
citation: "21 C.F.R. § 880.2930"
title: "21"
number: "880.2930"
heading: "Apgar timer."
url: "https://uscodex.org/cfr/21/880.2930"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 880.9](/cfr/21/880.9.md). The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in [part 820](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[63 FR 59718, Nov. 5, 1998, as amended at 90 FR 55986, Dec. 4, 2025]

### 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

[63 FR 59718, Nov. 5, 1998, as amended at 90 FR 55986, Dec. 4, 2025]