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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 K173952
Device Name Universal SmartECG
Applicant
VectraCor, Inc.
785 Totowa Rd. Suite 100
Totowa,  NJ  07512
Applicant Contact Andrew Schreck
Correspondent
VectraCor, Inc.
785 Totowa Rd. Suite 100
Totowa,  NJ  07512
Correspondent Contact Andrew Schreck
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
MLD  
Date Received12/27/2017
Decision Date 08/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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