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FDA 510(k) Application Details - K121871
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K121871
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 ANDREW MILLER
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
06/27/2012
Decision Date
07/03/2012
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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