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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 K101078
Device Name BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM
Applicant
Bl Healthcare, Inc.
33 Commercial St., Suite #3
Foxboro,  MA  02035
Applicant Contact MICHAEL MATHUR
Correspondent
Bl Healthcare, Inc.
33 Commercial St., Suite #3
Foxboro,  MA  02035
Correspondent Contact MICHAEL MATHUR
Regulation Number870.2910
Classification Product Code
DRG  
Date Received04/19/2010
Decision Date 05/10/2010
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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