510(k) K811424
- Device
- ELECTRONIC APGAR TIMER
- Applicant
- PT&E
- 510(k) number
- K811424
- Product code
- LHB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-07-09
- Date received
- 1981-05-22
- Regulation
- 880.2930
- Classification name
- Timer, Apgar
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3013445151
- 3002807523
- 3006897996
- 3005652389
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LHB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K834129 | MEDELA APGAR TIMER | Medela, Inc. | 1984-01-10 |
Legacy Summary#
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FDA Review#
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