LHB · Timer, Apgar
General Hospital · 21 CFR 880.2930 · Class 1
Overview
| Product Code | LHB |
|---|---|
| Device Name | Timer, Apgar |
| Regulation | 21 CFR 880.2930 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K834129 | MEDELA APGAR TIMER | Medela, Inc. | Jan 10, 1984 | SESE |
| K811424 | ELECTRONIC APGAR TIMER | Pt&E | Jul 9, 1981 | SESE |
Top Applicants
- Medela, Inc. — 1 clearance
- Pt&E — 1 clearance
