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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 K110503
Device Name AIRSTRIP REMOTE PATIENT MONITORING (RPM)
Applicant
AIRSTRIP TECHNOLOGIES, LP
3303 OAKWELL CT., SUITE 200
SAN ANTONIO,  TX  78218
Applicant Contact ANDY MILLER
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 Received02/22/2011
Decision Date 03/10/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party Yes
Combination Product No
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