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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 K133394
Device Name AIRSTRIP REMOTE PATIENT MONITORING
Applicant
AIRSTRIP TECHNOLOGIES, LP
335 E. SONTERRA BLVD.
SUITE 200
san antonio,  TX  78258
Applicant Contact robert a miller
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/05/2013
Decision Date 02/06/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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