FDA 510(k) Application Details - K073242

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K073242
Device Name Generator, Oxygen, Portable
Applicant DELPHI MEDICAL SYSTEMS
5725 DELPHI DRIVE
TROY, MI 48098 US
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Contact GILBERT ROQUE
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 11/19/2007
Decision Date 01/03/2008
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 Y
Expedited Review



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