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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 K930786
Device Name EPCOR
Applicant
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Applicant Contact KATHLEEN RUTHERFORD
Correspondent
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Correspondent Contact KATHLEEN RUTHERFORD
Regulation Number870.2350
Classification Product Code
DRW  
Date Received02/16/1993
Decision Date 09/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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