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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K073038
Device Name CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
Applicant
Carematix, Inc.
120 S. Riverside Plaza
Suite 2100
Chicago,  IL  60606
Applicant Contact SUKHWANT KHANUJA
Correspondent
Carematix, Inc.
120 S. Riverside Plaza
Suite 2100
Chicago,  IL  60606
Correspondent Contact SUKHWANT KHANUJA
Regulation Number870.2910
Classification Product Code
DRG  
Date Received10/29/2007
Decision Date 01/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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