Specular Microscope CEM-530— 510(k) K173980

Substantially Equivalent

Nidek Co., Ltd.

FDA 510(k) clearance K173980 for Specular Microscope CEM-530, Substantially Equivalent on 2018-03-14. Applicant: Nidek Co., Ltd..

Clearance details

Applicant: Nidek Co., Ltd.
Product code: Code NQE
Advisory panel: Ophthalmic
Date received: 2017-12-29
Decision date: 2018-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gamagori, JP

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