IVUE, MODEL 100

Tomography, Optical Coherence

OPTOVUE, INC.

The following data is part of a premarket notification filed by Optovue, Inc. with the FDA for Ivue, Model 100.

Pre-market Notification Details

Device IDK091404
510k NumberK091404
Device Name:IVUE, MODEL 100
ClassificationTomography, Optical Coherence
Applicant OPTOVUE, INC. 45531 NORTHPORT LOOP W. Fremont,  CA  94538
ContactAzimun Jamal
CorrespondentAzimun Jamal
OPTOVUE, INC. 45531 NORTHPORT LOOP W. Fremont,  CA  94538
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-12
Decision Date2010-04-22
Summary:summary

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