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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K040357
Device Name M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II
Applicant
Philips Medical Systems, Inc.
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Applicant Contact DAVE OSBORN
Correspondent
Philips Medical Systems, Inc.
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Correspondent Contact DAVE OSBORN
Regulation Number870.1025
Classification Product Code
MHX  
Date Received02/13/2004
Decision Date 03/03/2004
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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