Clearance Summary
TRIP TONOMETRY CATHETER, 16F received FDA 510(k) clearance under submission number K983366, sponsored by Datex-Engstrom, Inc.. 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 1998-12-23.
- Submission: K983366
- Applicant / Sponsor: Datex-Engstrom, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1998-12-23
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.