K071839 is an FDA 510(k) clearance for the SOCT COPERNICUS, MODEL 15205. This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Reichert, Inc. (Depew, US). The FDA issued a Cleared decision on February 27, 2008, 237 days after receiving the submission on July 5, 2007.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570. Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases..
| 510(k) Number | K071839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2007 |
| Decision Date | February 27, 2008 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OBO - Tomography, Optical Coherence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |
| Definition | Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases. |