FDA 510(k) Application Details - K090269

Device Classification Name System, Monitoring, Perinatal

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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
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Regulation Number 884.2740

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Classification Product Code HGM
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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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