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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, network and communication, physiological monitors
510(k) Number K160862
Device Name AirStrip RPM
Applicant
AirStrip Technologies, Inc.
335 E. Sonterra Blvd, Suite 200
san antonio,  TX  78258
Applicant Contact andy miller
Correspondent
Certified Compliance Solutions, Inc.
11665 Avena Place #203
san diego,  CA  92128 -2504
Correspondent Contact curtis m. egan
Regulation Number870.2300
Classification Product Code
MSX  
Date Received03/29/2016
Decision Date 09/19/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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