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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 AVENUE, 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
Recalls CDRH Recalls
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