The following data is part of a premarket notification filed by Kowa Co. Ltd. with the FDA for Kowa Vx-20.
| Device ID | K112330 |
| 510k Number | K112330 |
| Device Name: | KOWA VX-20 |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | KOWA CO. LTD. 4-14, NIHONBASHI-HONCHO 3-CHOME, CHUO-KU Tokyo, JP 103-8433 |
| Contact | Hiroyuki Koide |
| Correspondent | Hiroyuki Koide KOWA CO. LTD. 4-14, NIHONBASHI-HONCHO 3-CHOME, CHUO-KU Tokyo, JP 103-8433 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-12 |
| Decision Date | 2012-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987646807278 | K112330 | 000 |