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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, monitoring, perinatal
510(k) Number K090061
Device Name AIRSTRIP OB
Applicant
AIRSTRIP TECHNOLOGIES, LP
3303 OAKWELL CT., SUITE 200
SAN ANTONIO,  TX  78218
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number884.2740
Classification Product Code
HGM  
Date Received01/09/2009
Decision Date 01/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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