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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 K020456
Device Name EASI 12 LEAD ALGORITHM
Applicant
Philips Medical Systems
1201b N. Rice Ave.
Oxnard,  CA 
Applicant Contact PAUL SCHRADER
Correspondent
Philips Medical Systems
1201b N. Rice Ave.
Oxnard,  CA 
Correspondent Contact PAUL SCHRADER
Regulation Number870.2350
Classification Product Code
DRW  
Date Received02/11/2002
Decision Date 07/09/2002
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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