Microperimeter MP-3, Microperimeter MP-3 Type S— 510(k) K190198

Name: FDA 510(k) clearance K190198
Creator: U.S. Food and Drug Administration
Published: 2019-04-01

Substantially Equivalent

Nidek Co., Ltd.

FDA 510(k) clearance K190198 for Microperimeter MP-3, Microperimeter MP-3 Type S, Substantially Equivalent on 2019-04-01. Applicant: Nidek Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nidek Co., Ltd.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2019-02-04
Decision date: 2019-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gamagori, JP

Download summary PDF View on FDA.gov ↗

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