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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K032103
Device Name PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
Applicant
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact SONGHUA ZHANG
Correspondent
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact SONGHUA ZHANG
Regulation Number870.2800
Classification Product Code
DSH  
Date Received07/08/2003
Decision Date 07/22/2003
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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