The following data is part of a premarket notification filed by Konan Medical, Inc. with the FDA for Image Storage System, Model Kss-400.
| Device ID | K081797 |
| 510k Number | K081797 |
| Device Name: | IMAGE STORAGE SYSTEM, MODEL KSS-400 |
| Classification | System, Image Management, Ophthalmic |
| 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 | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-25 |
| Decision Date | 2009-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582275250428 | K081797 | 000 |