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510(k) K190198

Microperimeter MP-3, Microperimeter MP-3 Type S by Nidek Co., Ltd. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2019
Date Received
February 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

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