K102543 is an FDA 510(k) clearance for the BRAVO PH MONITORING SYSTEM AND ACCESSORIES. This device is classified as a Electrode, Ph, Stomach (Class I - General Controls, product code FFT).
Submitted by Given Imaging , Ltd. (Yoqneam, IL). The FDA issued a Cleared decision on December 1, 2010, 89 days after receiving the submission on September 3, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1400.
| 510(k) Number | K102543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2010 |
| Decision Date | December 01, 2010 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFT — Electrode, Ph, Stomach |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1400 |