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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, thermal regulating
510(k) Number K132454
Device Name VITAHEAT PATIENT WARMING SYSTEM
Applicant
VITAHEAT MEDICAL, LLC
1585 BEVERLY DR. #121
AURORA,  IL  60502
Applicant Contact JACK SLOVICK
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received08/06/2013
Decision Date 10/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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