FDA 510(k) Application Details - K090421

Device Classification Name Conserver, Oxygen

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510(K) Number K090421
Device Name Conserver, Oxygen
Applicant INSPIRED TECHNOLOGIES, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL 34134-2958 US
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Contact PAUL DRYDEN
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Regulation Number 868.5905

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Classification Product Code NFB
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Date Received 02/18/2009
Decision Date 05/29/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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