Clearance Summary
PROXIMA 1 PH MONITOR received FDA 510(k) clearance under submission number K881706, sponsored by Technomanagement, Inc. C/O C.G.. 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 1988-07-12.
- Submission: K881706
- Applicant / Sponsor: Technomanagement, Inc. C/O C.G.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1400
- Decision date: 1988-07-12
Classification & Regulation
This clearance is catalogued under FDA product code FFT and 21 CFR 876.1400, within the Gastroenterology, Urology review panel as a Class I device.