KOWA GENESIS-D HAND-HELD RETINAL CAMERA— 510(k) K050271

Substantially Equivalent

Kowa Co. , Ltd.

FDA 510(k) clearance K050271 for KOWA GENESIS-D HAND-HELD RETINAL CAMERA, Substantially Equivalent on 2005-11-03. Applicant: Kowa Co. , Ltd..

Clearance details

Applicant: Kowa Co. , Ltd.
Product code: Code HKI
Advisory panel: Ophthalmic
Date received: 2005-02-04
Decision date: 2005-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuo-Ku, Tokyo, JP

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