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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 K051470
Device Name REMOTE CARE MANAGEMENT SYSTEMS (RCMS)
Applicant
Bl Healthcare, Inc.
33 Commercial St., Suite #3
Foxboro,  MA  02035
Applicant Contact MICHAEL MATHUR
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number870.2910
Classification Product Code
DRG  
Date Received06/03/2005
Decision Date 06/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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