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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 K063047
Device Name MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
Applicant
Medhot Thermal Imaging, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SID MATHUR
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received10/04/2006
Decision Date 10/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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