The following data is part of a premarket notification filed by Konan Medical, Inc. with the FDA for Kerato Analyzer (eka).
| Device ID | K040373 |
| 510k Number | K040373 |
| Device Name: | KERATO ANALYZER (EKA) |
| Classification | Microscope, Specular |
| Applicant | KONAN MEDICAL, INC. 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers KONAN MEDICAL, INC. 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Product Code | NQE |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582275250404 | K040373 | 000 |