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FDA 510(k) Application Details - K153079
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K153079
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
AXEO MEDICAL TECHNOLOGIES, LLC
971 VIRGINIA AVENUE
SUITE A
PALM HARBOR, FL 34683 US
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Contact
Stamatios Parimeros
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MWI
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More FDA Info for this Product Code
Date Received
10/23/2015
Decision Date
03/17/2016
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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