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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Lead Switching, Electrocardiograph
510(k) Number K033513
Device Name EASI ECG ALGORITHM
Applicant
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Applicant Contact DAVID OSBORN
Correspondent
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Correspondent Contact DAVID OSBORN
Regulation Number870.2350
Classification Product Code
DRW  
Date Received11/06/2003
Decision Date 01/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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