The following data is part of a premarket notification filed by Optomed Oy with the FDA for Optomed Aurora Camera With Aurora Retinal Module And Aurora Anterior Module.
| Device ID | K180378 |
| 510k Number | K180378 |
| Device Name: | Optomed Aurora Camera With Aurora Retinal Module And Aurora Anterior Module |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Optomed Oy Yrttipellontie 1 Oulu, FI 90230 |
| Contact | Jyri Leskela |
| Correspondent | Jyri Leskela Optomed Oy Yrttipellontie 1 Oulu, FI 90230 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-12 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430046260832 | K180378 | 000 |
| 06430046260856 | K180378 | 000 |
| 06430046260887 | K180378 | 000 |
| 06430046260870 | K180378 | 000 |
| 06430046260795 | K180378 | 000 |
| 06430046260757 | K180378 | 000 |
| 00811608012261 | K180378 | 000 |
| 00811608012254 | K180378 | 000 |