Clearance Summary
TONOMITOR(TM) received FDA 510(k) clearance under submission number K870606, sponsored by Tonometrics Holdings SA C/O Mackeen Consultants. 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 1987-04-10.
- Submission: K870606
- Applicant / Sponsor: Tonometrics Holdings SA C/O Mackeen Consultants
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1400
- Decision date: 1987-04-10
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.