K071250 is an FDA 510(k) clearance for the CA, MODEL: CAM. This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on September 28, 2007, 147 days after receiving the submission on May 4, 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 | K071250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2007 |
| Decision Date | September 28, 2007 |
| Days to Decision | 147 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. |