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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor,physiological,patient(without arrhythmia detection or alarms)
510(k) Number K122133
Device Name AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
Original Applicant
AIRSTRIP TECHNOLOGIES, LP
335 e. sonterra blvd.
suite 200
san antonio,  TX  78258
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/18/2012
Decision Date 10/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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