Clearance Summary
PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR received FDA 510(k) clearance under submission number K946080, sponsored by Portable Power Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1995-08-02.
- Submission: K946080
- Applicant / Sponsor: Portable Power Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1500
- Decision date: 1995-08-02
Classification & Regulation
This clearance is catalogued under FDA product code FCO and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class I device.