Clearance Summary
DISTENDER SERIES II BAROSTAT received FDA 510(k) clearance under submission number K991288, sponsored by G & J Electronics, 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 1999-06-08.
- Submission: K991288
- Applicant / Sponsor: G & J Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 1999-06-08
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.