The following data is part of a premarket notification filed by Optomed Oy with the FDA for Haag-streit Fundus Module 300.
| Device ID | K163021 |
| 510k Number | K163021 |
| Device Name: | HAAG-STREIT FUNDUS MODULE 300 |
| 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 | 2016-10-31 |
| Decision Date | 2017-04-11 |
| Summary: | summary |