MEDELA APGAR TIMER
FDA 510(k) clearance K834129 · decided 1984-01-10
Clearance details
- K-number
- K834129
- Device name
- MEDELA APGAR TIMER
- Applicant
- Medela, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-30
- Decision date
- 1984-01-10
- Days to decision
- 41 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
+ Add to Predicate Builder ◉ Watch Medela
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ELECTRONIC APGAR TIMER (K811424) | Pt&E | 1981-07-09 |
Recalls involving this device
No recalls on record reference this clearance.