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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 K100133
Device Name AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1
Original Applicant
AIRSTRIP TECHNOLOGIES, LP
3303 oakwell ct., suite 200
san antonio,  TX  78218
Original Contact william cameron powell
Regulation Number870.2300
Classification Product Code
MWI  
Date Received01/19/2010
Decision Date 07/23/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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