Clearance Summary
12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON received FDA 510(k) clearance under submission number K910144, 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 1991-07-17.
- Submission: K910144
- Applicant / Sponsor: Physio-Control Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5300
- Decision date: 1991-07-17
Classification & Regulation
This clearance is catalogued under FDA product code LDD and 21 CFR 870.5300, within the Cardiovascular review panel as a Class II device.