The following data is part of a premarket notification filed by Optomed Oy with the FDA for Optomed Smartscope, Model M3-1 Ey1.
| Device ID | K092056 |
| 510k Number | K092056 |
| Device Name: | OPTOMED SMARTSCOPE, MODEL M3-1 EY1 |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | OPTOMED OY HALLITUSKATU 13-17 D 96 Oulu, FI 90100 |
| Contact | Laura Ojala |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-07-07 |
| Decision Date | 2009-10-01 |
| Summary: | summary |