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510(k) K200275

OVision Imaging System by Ophthalmic Labs, Inc. — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2020
Date Received
February 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Management, Ophthalmic
Device Class
Class II
Regulation Number
892.2050
Review Panel
OP
Submission Type

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