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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 K071564
Device Name MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921
Applicant
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact RICK SCHUL
Correspondent
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact RICK SCHUL
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DXN   FRW  
Date Received06/07/2007
Decision Date 08/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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