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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 K171928
Device Name Med-Hot Thermal Imaging Systems
Applicant
Med-Hot Thermal Imaging, Inc.
5120 S. Florida Ave. Suite 301
Lakeland,  FL  33813
Applicant Contact Carol Chandler
Correspondent
Smith Associates
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact E. J. Smith
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received06/27/2017
Decision Date 12/08/2017
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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