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FDA 510(k) Application Details - K140852
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
510(K) Number
K140852
Device Name
System,Network And Communication,Physiological Monitors
Applicant
VECTRACOR, INC
785 TOTOWA ROAD
SUITE, 100
TOTOWA, NJ 07512 US
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Contact
BRAD S SCHRECK
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/03/2014
Decision Date
01/30/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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