Clearance Summary
MODEL 1858 CAVRO/PRESSURE MODULE received FDA 510(k) clearance under submission number K872077, sponsored by Life-Tech Intl., 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 1987-08-27.
- Submission: K872077
- Applicant / Sponsor: Life-Tech Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1800
- Decision date: 1987-08-27
Classification & Regulation
This clearance is catalogued under FDA product code EXY and 21 CFR 876.1800, within the Gastroenterology, Urology review panel as a Class II device.