Microperimeter MP-3, Microperimeter MP-3 Type S

Camera, Ophthalmic, Ac-powered

Nidek Co., Ltd

The following data is part of a premarket notification filed by Nidek Co., Ltd with the FDA for Microperimeter Mp-3, Microperimeter Mp-3 Type S.

Pre-market Notification Details

Device IDK190198
510k NumberK190198
Device Name:Microperimeter MP-3, Microperimeter MP-3 Type S
ClassificationCamera, Ophthalmic, Ac-powered
Applicant Nidek Co., Ltd 34-14 Maehama, Hiroishi-cho Gamagori,  JP 443-0038
ContactMizuno Yoneji
CorrespondentEnrico Bisson
Nidek Technologies Srl Via Dell'Artigianato, 6/A Albignasego,  IT 35020
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-04
Decision Date2019-04-01

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