The following data is part of a premarket notification filed by Optomed Oy with the FDA for Optomed Smartscope M5 / Optomed Smartscope Ey4 / Optomed Smartscope Es2.
| Device ID | K132186 |
| 510k Number | K132186 |
| Device Name: | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | OPTOMED OY Hallituskatu 13-17 D Oulu, FI 90100 |
| Contact | Jyri Leskela, Quality Manager |
| Correspondent | Jyri Leskela, Quality Manager OPTOMED OY Hallituskatu 13-17 D Oulu, FI 90100 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-15 |
| Decision Date | 2013-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430046260672 | K132186 | 000 |
| 06430046260658 | K132186 | 000 |