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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 K103214
Device Name M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130
Applicant
Lifeline Systems, Inc.
111 Lawrence St.
Framingham,  MA  01702
Applicant Contact CARLOS O ACOSTA
Correspondent
Lifeline Systems, Inc.
111 Lawrence St.
Framingham,  MA  01702
Correspondent Contact CARLOS O ACOSTA
Regulation Number870.2910
Classification Product Code
DRG  
Date Received11/01/2010
Decision Date 12/01/2010
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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