Clearance Summary
BRAVO PH MONITORING SYSTEM AND ACCESSORIES received FDA 510(k) clearance under submission number K102543, sponsored by Given Imaging , Ltd.. 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 2010-12-01.
- Submission: K102543
- Applicant / Sponsor: Given Imaging , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1400
- Decision date: 2010-12-01
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.