The following data is part of a premarket notification filed by Optomedical Technologies Gmbh with the FDA for Oct-camera Id 21101a3.
| Device ID | K200516 |
| 510k Number | K200516 |
| Device Name: | OCT-Camera ID 21101A3 |
| Classification | Tomography, Optical Coherence |
| Applicant | OptoMedical Technologies GmbH Maria-Goeppert-Strasse 9 Luebeck, DE 23562 |
| Contact | Julia Behrens |
| Correspondent | Oliver Eikenberg Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-02 |
| Decision Date | 2020-09-02 |