The following data is part of a premarket notification filed by Reichert, Inc. with the FDA for Soct Copernicus, Model 15205.
| Device ID | K071839 |
| 510k Number | K071839 |
| Device Name: | SOCT COPERNICUS, MODEL 15205 |
| Classification | Tomography, Optical Coherence |
| Applicant | REICHERT, INC. 3362 WALDEN AVE. Depew, NY 14043 |
| Contact | Sandra Brown |
| Correspondent | Sandra Brown REICHERT, INC. 3362 WALDEN AVE. Depew, NY 14043 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-05 |
| Decision Date | 2008-02-27 |
| Summary: | summary |