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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic (Adjunctive Use)
510(k) Number K200999
Device Name Thermidas IR System (ThIR-A615)
Applicant
Thermidas Americas, Inc.
7912 Sailboat Key Blvd., Suite 508
South Pasadena,  FL  33707
Applicant Contact Karo Kujanpaa
Correspondent
Gunster, Yoakley & Stewart, P.A.
225 Water St., Suite 1750
Jacksonville,  FL  32202
Correspondent Contact Samantha L Prokop
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received04/16/2020
Decision Date 01/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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