Thermidas IR System (ThIR-A615)

System, Telethermographic (adjunctive Use)

Thermidas Americas, Inc.

The following data is part of a premarket notification filed by Thermidas Americas, Inc. with the FDA for Thermidas Ir System (thir-a615).

Pre-market Notification Details

Device IDK200999
510k NumberK200999
Device Name:Thermidas IR System (ThIR-A615)
ClassificationSystem, Telethermographic (adjunctive Use)
Applicant Thermidas Americas, Inc. 7912 Sailboat Key Blvd., Suite 508 South Pasadena,  FL  33707
ContactKaro Kujanpaa
CorrespondentSamantha L Prokop
Gunster, Yoakley & Stewart, P.A. 225 Water Street, Suite 1750 Jacksonville,  FL  32202
Product CodeLHQ  
CFR Regulation Number884.2980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-16
Decision Date2021-01-06

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