K040373 is an FDA 510(k) clearance for the KERATO ANALYZER (EKA). This device is classified as a Microscope, Specular (Class II - Special Controls, product code NQE).
Submitted by Konan Medical, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on March 19, 2004, 31 days after receiving the submission on February 17, 2004.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850. Specular Microscopes Are Used For The Microscopic Imaging And Assessment Of The Corneal Endothelial Cell Layer In Vivo Or In Vitro..
| 510(k) Number | K040373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2004 |
| Decision Date | March 19, 2004 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NQE - Microscope, Specular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1850 |
| Definition | Specular Microscopes Are Used For The Microscopic Imaging And Assessment Of The Corneal Endothelial Cell Layer In Vivo Or In Vitro. |