K002028 is an FDA 510(k) clearance for the BRAVO PH MONITORING SYSTEM, a Electrode, Ph, Stomach (Class I — General Controls, product code FFT), submitted by Endonetics, Inc. (Los Gatos, US). The FDA issued a Cleared decision on September 29, 2000, 88 days after receiving the submission on July 3, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1400.
| 510(k) Number | K002028 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 03, 2000 |
| Decision Date | September 29, 2000 |
| Days to Decision | 88 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 |