The following data is part of a premarket notification filed by Kowa Company, Ltd. with the FDA for Kowa Dr-1a.
| Device ID | K190573 |
| 510k Number | K190573 |
| Device Name: | KOWA DR-1a |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Kowa Company, Ltd. 3-1, Chofugaoka 3-Chome Chofu, JP 1820021 |
| Contact | Nariaki Morita |
| Correspondent | Nariaki Morita Kowa Company, Ltd. 3-1, Chofugaoka 3-Chome Chofu, JP 1820021 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-06 |
| Decision Date | 2019-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987646807728 | K190573 | 000 |