FDA 510(k) Application Details - K133450

Device Classification Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

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510(K) Number K133450
Device Name Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant AIRSTRIP TECHNOLOGIES, LP
335 E. SONTERRA BLVD.
SUITE 200
SAN ANTONIO, TX 78258 US
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Contact ROBERT A MILLER
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Regulation Number 870.2300

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Classification Product Code MWI
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Date Received 11/11/2013
Decision Date 02/14/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party Y
Expedited Review



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