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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K140852
Device Name VECTRAPLEX CMS
Applicant
Vectracor, Inc.
785 Totowa Rd. Suite 100
Totowa,  NJ  07512
Applicant Contact BRAD S SCHRECK
Correspondent
Vectracor, Inc.
785 Totowa Rd. Suite 100
Totowa,  NJ  07512
Correspondent Contact BRAD S SCHRECK
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
MHX   MLD  
Date Received04/03/2014
Decision Date 01/30/2015
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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