Clearance Summary
PH ANALYSIS MODULE received FDA 510(k) clearance under submission number K961346, sponsored by Synectics-Dantec. 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 1997-01-29.
- Submission: K961346
- Applicant / Sponsor: Synectics-Dantec
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1400
- Decision date: 1997-01-29
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.