K925405 is an FDA 510(k) clearance for the ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF., a Electrode, Ph, Stomach (Class I — General Controls, product code FFT), submitted by Synectics-Dantec (Irving, US). The FDA issued a Cleared decision on September 30, 1994, 704 days after receiving the submission on October 26, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1400.
| 510(k) Number | K925405 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 26, 1992 |
| Decision Date | September 30, 1994 |
| Days to Decision | 704 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FFT — Electrode, Ph, Stomach |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.1400 |