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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
Applicant
AIRSTRIP TECHNOLOGIES, LP
335 E. SONTERRA BLVD.
SUITE 200
SAN ANTONIO,  TX  78258
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/18/2012
Decision Date 10/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
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