The following data is part of a premarket notification filed by Konan Medical, Inc. with the FDA for Cellchek 20 Rc.
| Device ID | K203244 |
| 510k Number | K203244 |
| Device Name: | CellChek 20 Rc |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Konan Medical, Inc. 10-29, Miyanishicho Nishinomiya, JP 662-0976 |
| Contact | Runa Emura |
| Correspondent | Alan Donald Matrix Medical Consulting, INC. 8880 Rio San Diego Drive Suite 800 San Diego, CA 92108 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-03 |
| Decision Date | 2021-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582275250657 | K203244 | 000 |