The following data is part of a premarket notification filed by Optomedical Technologies Gmbh with the FDA for Oct-camera.
| Device ID | K142953 |
| 510k Number | K142953 |
| Device Name: | OCT-Camera |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | OptoMedical Technologies GmbH Maria-Goeppert-Strasse 1 Luebeck, DE 23562 |
| Contact | Alexander Holzhey |
| Correspondent | Dirk Meier Emergo Group Prinsessegracht 20 The Hague, NL 2514ap |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-10 |
| Decision Date | 2015-03-04 |
| Summary: | summary |