K914397 is an FDA 510(k) clearance for the OXFORD OPTRONIX MPM 3S. This device is classified as a Lamp, Endoscope, Incandescent (Class II - Special Controls, product code FTI).
Submitted by Dia-Stron, Ltd. (Broomall, US). The FDA issued a Cleared decision on November 16, 1992, 412 days after receiving the submission on October 1, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K914397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 1991 |
| Decision Date | November 16, 1992 |
| Days to Decision | 412 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FTI — Lamp, Endoscope, Incandescent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |