The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Medela Apgar Timer.
| Device ID | K834129 |
| 510k Number | K834129 |
| Device Name: | MEDELA APGAR TIMER |
| Classification | Timer, Apgar |
| Applicant | MEDELA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LHB |
| CFR Regulation Number | 880.2930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-30 |
| Decision Date | 1984-01-10 |