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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K020708
Device Name PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
Applicant
Philips Medical Systems, Inc.
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Applicant Contact SONGHUA ZHANG
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact N.E. DEVINE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/05/2002
Decision Date 04/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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