21 CFR 880.2930 — Timer, Apgar
General Hospital (HO) · Part 880 Subpart C—General Hospital and Personal Use Monitoring Devices · § 880.2930
Identification
The Apgar timer is a device intended to alert a health care provider to take the Apgar score of a newborn infant.
Classification Rationale
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 of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LHB | Timer, Apgar | 1 | 2 |
