Clearance Summary
ADR-10600(ADR 400),10601 (ADR 300) received FDA 510(k) clearance under submission number K791342, sponsored by Physio-Control Corp.. 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 1979-11-16.
- Submission: K791342
- Applicant / Sponsor: Physio-Control Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1979-11-16
Classification & Regulation
This clearance is catalogued under FDA product code FKX and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.