Clearance Summary
PNEUPAC RESUSCITATOR INSTANT ACTION SET received FDA 510(k) clearance under submission number K792452, sponsored by Pneupac , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1980-02-05.
- Submission: K792452
- Applicant / Sponsor: Pneupac , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5200
- Decision date: 1980-02-05
Classification & Regulation
This clearance is catalogued under FDA product code DRM and 21 CFR 870.5200, within the Cardiovascular review panel as a Class II device.