OptikView GUP2103CMI

Display, Diagnostic Radiology

The Linden Group Corp

The following data is part of a premarket notification filed by The Linden Group Corp with the FDA for Optikview Gup2103cmi.

Pre-market Notification Details

Device IDK191705
510k NumberK191705
Device Name:OptikView GUP2103CMI
ClassificationDisplay, Diagnostic Radiology
Applicant The Linden Group Corp 2B Wing Drive Cedar Knolls,  NJ  07927
ContactJames Chen
CorrespondentMarc Leppla
Qubyx Software Technologies Inc 501 Silverside Road, Suite 105 Wilmington,  DE  19809
Product CodePGY  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-26
Decision Date2020-03-16

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