The following data is part of a premarket notification filed by Kowa Co. Ltd. with the FDA for Kowa Genesis-d Hand-held Retinal Camera.
| Device ID | K050271 |
| 510k Number | K050271 |
| Device Name: | KOWA GENESIS-D HAND-HELD RETINAL CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | KOWA CO. LTD. 4-14, NIHONBASHI-HONCHO 3-CHOME Chuo-ku, Tokyo, JP 103-8433 |
| Contact | Satohiko Takanishi |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-02-04 |
| Decision Date | 2005-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987646803973 | K050271 | 000 |