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FDA 510(k) Application Details - K172959
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K172959
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
PeraHealth, Inc.
6302 Fairview Rd.,Suite 310
Charlotte, NC 28210 US
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Contact
Joseph Beals
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Regulation Number
870.2300
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Classification Product Code
MWI
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More FDA Info for this Product Code
Date Received
09/26/2017
Decision Date
05/01/2018
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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