K950091 is an FDA 510(k) clearance for the KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).
Submitted by Konan Medical, Inc. (Hyogo, JP). The FDA issued a Cleared decision on March 1, 1995, 50 days after receiving the submission on January 10, 1995.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K950091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1995 |
| Decision Date | March 01, 1995 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKI - Camera, Ophthalmic, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1120 |