Clearance Summary
ELECTRONIC APGAR TIMER received FDA 510(k) clearance under submission number K811424, sponsored by Pt&E. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1981-07-09.
- Submission: K811424
- Applicant / Sponsor: Pt&E
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2930
- Decision date: 1981-07-09
Classification & Regulation
This clearance is catalogued under FDA product code LHB and 21 CFR 880.2930, within the General Hospital review panel as a Class I device.