OVision Imaging System

System, Image Management, Ophthalmic

Ophthalmic Labs, Inc.

The following data is part of a premarket notification filed by Ophthalmic Labs, Inc. with the FDA for Ovision Imaging System.

Pre-market Notification Details

Device IDK200275
510k NumberK200275
Device Name:OVision Imaging System
ClassificationSystem, Image Management, Ophthalmic
Applicant Ophthalmic Labs, Inc. 18 Berlin Ave Milton,  MA  02186
ContactMatthew Carnevale
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeNFJ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelOphthalmic
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-02-04
Decision Date2020-03-03

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