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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
Model TCX-I 2.0
Device Name TCX-I REMOTE CARE MANAGEMENT SYSTEM
Original Applicant
BL HEALTHCARE, INC.
33 commercial st., suite #3
foxboro,  MA  02035
Original 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 (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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