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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 K102378
Device Name VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI
Applicant
Vectracor, Inc.
169 Union Blvd.
Totowa,  NJ  07512
Applicant Contact BRAD S SCHRECK
Correspondent
Vectracor, Inc.
169 Union Blvd.
Totowa,  NJ  07512
Correspondent Contact BRAD S SCHRECK
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
MLD  
Date Received08/20/2010
Decision Date 11/02/2011
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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