Clearance Summary
LIMB LEAD SEL. (ECG LEAD SWITCHING AD.) received FDA 510(k) clearance under submission number K761210, 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 1976-12-21.
- Submission: K761210
- Applicant / Sponsor: Physio-Control Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2350
- Decision date: 1976-12-21
Classification & Regulation
This clearance is catalogued under FDA product code DRW and 21 CFR 870.2350, within the Cardiovascular review panel as a Class II device.