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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 K121712
Device Name AIRSTRIP RPM FOR LIFENET CONSULT
Applicant
AIRSTRIP TECHNOLOGIES, INC.
335 E Sonterra Blvd Ste 200
SAN ANTONIO,  TX  78258
Applicant Contact ROBERT A MILLER
Correspondent
AIRSTRIP TECHNOLOGIES, INC.
335 E Sonterra Blvd Ste 200
SAN ANTONIO,  TX  78258
Correspondent Contact ROBERT A MILLER
Regulation Number870.2300
Classification Product Code
MSX  
Date Received06/11/2012
Decision Date 11/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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