The following data is part of a premarket notification filed by Opko Health, Inc. with the FDA for Spectral Oct/slo.
| Device ID | K080460 |
| 510k Number | K080460 |
| Device Name: | SPECTRAL OCT/SLO |
| Classification | Tomography, Optical Coherence |
| Applicant | OPKO HEALTH, INC. 4400 BISCAYNE BLVD. Miami, FL 33137 |
| Contact | Jane Hsiao |
| Correspondent | Jane Hsiao OPKO HEALTH, INC. 4400 BISCAYNE BLVD. Miami, FL 33137 |
| Product Code | OBO |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-20 |
| Decision Date | 2008-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05057056003856 | K080460 | 000 |