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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K190198
Device Name Microperimeter MP-3, Microperimeter MP-3 Type S
Applicant
Nidek Co., Ltd.
34-14 Maehama, Hiroishi-Cho
Gamagori,  JP 443-0038
Applicant Contact Mizuno Yoneji
Correspondent
Nidek Technologies Srl
Via Dell'Artigianato, 6/A
Albignasego,  IT 35020
Correspondent Contact Enrico Bisson
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
HPT  
Date Received02/04/2019
Decision Date 04/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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