Clearance Summary
PRESSURE MONITOR MANOMETRIC SYS. received FDA 510(k) clearance under submission number K771265, 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 1977-11-22.
- Submission: K771265
- Applicant / Sponsor: Physio-Control Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 1977-11-22
Classification & Regulation
This clearance is catalogued under FDA product code KLA and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.