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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 K041741
Device Name M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
Applicant
Philips Medical Systems, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact BARRY WYSHOGROD
Correspondent
Philips Medical Systems, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact BARRY WYSHOGROD
Regulation Number870.1025
Classification Product Code
MHX  
Date Received06/28/2004
Decision Date 07/21/2004
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
Recalls CDRH Recalls
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