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FDA 510(k) Application Details - K112235
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K112235
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
AIRSTRIP TECHNOLOGIES, LP
3303 OAKWELL CT., SUITE 200
SAN ANTONIO, TX 78218 US
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Contact
ANDY MILLER
Other 510(k) Applications for this Contact
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
08/04/2011
Decision Date
08/26/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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