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FDA 510(k) Application Details - K090269
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K090269
Device Name
System, Monitoring, Perinatal
Applicant
AIRSTRIP TECHNOLOGIES, LP
3303 OAKWELL CT., SUITE 200
SAN ANTONIO, TX 78218 US
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Contact
WM CAMERON POWELL
Other 510(k) Applications for this Contact
Regulation Number
884.2740
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Classification Product Code
HGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/03/2009
Decision Date
02/13/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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