FDA 510(k) Application Details - K042944

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K042944
Device Name Generator, Oxygen, Portable
Applicant IN-X CORPORATION
6753 EAST 47TH AVE.
UNIT D
DENVER, CO 80216 US
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Contact DOUGLAS POWELL
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 10/25/2004
Decision Date 04/15/2005
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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