Electronic Apgar Timer
FDA 510(k) K811424 · Pt&E
510(k) numberK811424
Submission
- Device name
- Electronic Apgar Timer
- Applicant
- Pt&E
Mchenry, IL, US - Received
- May 22, 1981
- Decision date
- July 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LHB – Timer, Apgar
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.2930
- Specialty
- General Hospital
Other 510(k)s with product code LHB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K834129 | Medela Apgar TimerLHB · Traditional | Medela, Inc. | 01/10/1984SE |
Questions and answers
When was Electronic Apgar Timer cleared by the FDA?
Electronic Apgar Timer (K811424) received a 510(k) decision of Substantially Equivalent on July 9, 1981, 48 days after the submission was received.
What is the product code of K811424?
The FDA product code is LHB – Timer, Apgar, a Class I (low risk) device regulated under 21 CFR 880.2930.