Clearance Summary
AMENDMENT LIFEPAK 8, NPN 052 received FDA 510(k) clearance under submission number K854117, sponsored by Physio-Control Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-01-13.
- Submission: K854117
- Applicant / Sponsor: Physio-Control Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5550
- Decision date: 1986-01-13
Classification & Regulation
This clearance is catalogued under FDA product code DRO and 21 CFR 870.5550, within the Cardiovascular review panel as a Class II device.