K822908 is an FDA 510(k) clearance for the COHERENT FUNDUSL RETINAL CAMERA. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).
Submitted by Coherent Medical Division (Mchenry, US). The FDA issued a Cleared decision on January 5, 1983, 97 days after receiving the submission on September 30, 1982.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K822908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 1982 |
| Decision Date | January 05, 1983 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HKI — Camera, Ophthalmic, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1120 |