K961346 is an FDA 510(k) clearance for the PH ANALYSIS MODULE, a Electrode, Ph, Stomach (Class I — General Controls, product code FFT), submitted by Synectics-Dantec (Sweden, SE). The FDA issued a Cleared decision on January 29, 1997, 320 days after receiving the submission on March 15, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1400.
| 510(k) Number | K961346 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 15, 1996 |
| Decision Date | January 29, 1997 |
| Days to Decision | 320 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 |