ELECTRONIC APGAR TIMER
FDA 510(k) clearance K811424 · decided 1981-07-09
Clearance details
- K-number
- K811424
- Device name
- ELECTRONIC APGAR TIMER
- Applicant
- Pt&E
- Decision
- Substantially Equivalent
- Date received
- 1981-05-22
- Decision date
- 1981-07-09
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- LHB
- Device class
- 1
- Regulation number
- 880.2930
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDELA APGAR TIMER (K834129) | Medela, Inc. | 1984-01-10 |
Recalls involving this device
No recalls on record reference this clearance.