K913387 is an FDA 510(k) clearance for the DIGITRAPPER MARK III. This device is classified as a Electrode, Ph, Stomach (Class I - General Controls, product code FFT).
Submitted by Synectics-Dantec (Sweden, SE). The FDA issued a Cleared decision on December 27, 1991, 151 days after receiving the submission on July 29, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1400.
| 510(k) Number | K913387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1991 |
| Decision Date | December 27, 1991 |
| Days to Decision | 151 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 |