FDA 510(k) Application Details - K050414

Device Classification Name Unit, Liquid-Oxygen, Portable

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510(K) Number K050414
Device Name Unit, Liquid-Oxygen, Portable
Applicant RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE, PA 15668 US
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Contact ZITA YURKO
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Regulation Number 868.5655

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Classification Product Code BYJ
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Date Received 02/18/2005
Decision Date 04/11/2005
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 Y
Expedited Review



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