Clearance Summary
SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E received FDA 510(k) clearance under submission number K850361, 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 1985-05-01.
- Submission: K850361
- Applicant / Sponsor: Synectics-Dantec
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1400
- Decision date: 1985-05-01
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.