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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 K113493
Device Name TCX-I REMOTE CARE MANAGEMENT SYSTEM
Applicant
Bl Healthcare, Inc.
33 Commercial St., Suite #3
Foxboro,  MA  02035
Applicant Contact MICHEAL MATHUR
Correspondent
Bl Healthcare, Inc.
33 Commercial St., Suite #3
Foxboro,  MA  02035
Correspondent Contact MICHEAL MATHUR
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
BZH   DQA   DQD   DXN   FLL  
GJS   LFR   NBW  
Date Received11/25/2011
Decision Date 12/21/2011
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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