The following data is part of a premarket notification filed by Kowa Co. Ltd. with the FDA for Kowa Vx-10i.
| Device ID | K062021 |
| 510k Number | K062021 |
| Device Name: | KOWA VX-10I |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | KOWA CO. LTD. 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 |
| Contact | Richard Phillips |
| Correspondent | Richard Phillips KOWA CO. LTD. 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-17 |
| Decision Date | 2006-11-01 |