K081797 is an FDA 510(k) clearance for the IMAGE STORAGE SYSTEM, MODEL KSS-400. This device is classified as a System, Image Management, Ophthalmic (Class II - Special Controls, product code NFJ).
Submitted by Konan Medical, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on January 22, 2009, 211 days after receiving the submission on June 25, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K081797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2008 |
| Decision Date | January 22, 2009 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NFJ - System, Image Management, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |