The following data is part of a premarket notification filed by Kowa Co. Ltd. with the FDA for Kowa Vx-10.
| Device ID | K043213 |
| 510k Number | K043213 |
| Device Name: | KOWA VX-10 |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | KOWA CO. LTD. 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 |
| Contact | Richard N Phillips |
| Correspondent | Richard N 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 | 2004-11-19 |
| Decision Date | 2005-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987646802006 | K043213 | 000 |