Clearance Summary
AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. received FDA 510(k) clearance under submission number K880581, 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 1988-08-11.
- Submission: K880581
- Applicant / Sponsor: Synectics-Dantec
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 1988-08-11
Classification & Regulation
This clearance is catalogued under FDA product code FFX and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.