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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 K232462
Device Name ThermPix Thermovisual Camera
Applicant
Usa Therm, Inc.
3100 Ray Ferrero Jr. Blvd., 5th Floor
Fort Lauderdale,  FL  33314
Applicant Contact Eric Heil
Correspondent
Medical Device Academy
345 Lincoln Hill Rd.
Shrewsbury,  VT  05387
Correspondent Contact Mary Vater
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received08/15/2023
Decision Date 09/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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