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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 K112235
Device Name AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
Applicant
AIRSTRIP TECHNOLOGIES, LP
3303 oakwell ct., suite 200
san antonio,  TX  78218
Contact andy miller
Regulation Number870.2300
Classification Product Code
MWI  
Date Received08/04/2011
Decision Date 08/26/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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