The following data is part of a premarket notification filed by Dia-stron, Ltd. with the FDA for Oxford Optronix Mpm 3s.
| Device ID | K914397 |
| 510k Number | K914397 |
| Device Name: | OXFORD OPTRONIX MPM 3S |
| Classification | Lamp, Endoscope, Incandescent |
| Applicant | DIA-STRON, LTD. 835-837 SUSSEX BLVD. Broomall, PA 19008 -4310 |
| Contact | Mr. S Rimdzius |
| Correspondent | Mr. S Rimdzius DIA-STRON, LTD. 835-837 SUSSEX BLVD. Broomall, PA 19008 -4310 |
| Product Code | FTI |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-01 |
| Decision Date | 1992-11-16 |