The following data is part of a premarket notification filed by Kowa Co. Ltd. with the FDA for Kowa Kt-800.
| Device ID | K053444 |
| 510k Number | K053444 |
| Device Name: | KOWA KT-800 |
| Classification | Tonometer, Ac-powered |
| Applicant | KOWA CO. LTD. 319 AKENO OBATA-CHO, WATARAI-GUN Mie-ken, JP 519-05 |
| Contact | Shinichi Yamanaka |
| Correspondent | Shinichi Yamanaka KOWA CO. LTD. 319 AKENO OBATA-CHO, WATARAI-GUN Mie-ken, JP 519-05 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-09 |
| Decision Date | 2006-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987646804109 | K053444 | 000 |