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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 K121871
Device Name AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
Applicant
AIRSTRIP TECHNOLOGIES, LP
335 e. sonterra blvd.
suite 200
san antonio,  TX  78258
Contact robert andrew miller
Regulation Number870.2300
Classification Product Code
MWI  
Date Received06/27/2012
Decision Date 07/03/2012
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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