INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM

System, Telethermographic (adjunctive Use)

IMAGE SYSTEMS, INC.

The following data is part of a premarket notification filed by Image Systems, Inc. with the FDA for Infraview/infrasion-telethermographic System.

Pre-market Notification Details

Device IDK844771
510k NumberK844771
Device Name:INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM
ClassificationSystem, Telethermographic (adjunctive Use)
Applicant IMAGE SYSTEMS, INC. 430 10TH.ST.N.W.STE.N-209 Atlanta,  GA  30318
ContactRichard P Hartwig
CorrespondentRichard P Hartwig
IMAGE SYSTEMS, INC. 430 10TH.ST.N.W.STE.N-209 Atlanta,  GA  30318
Product CodeLHQ  
CFR Regulation Number884.2980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-07
Decision Date1985-02-27

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