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FDA 510(k) Application Details - K112489
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
510(K) Number
K112489
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
RESMED LTD.
1 ELIZABETH MACARTHUR DR
BELLA VISTA NEWSOUTH WALES 2153 AU
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Contact
KIM K LEE
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Regulation Number
868.5905
More FDA Info for this Regulation Number
Classification Product Code
BZD
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More FDA Info for this Product Code
Date Received
08/29/2011
Decision Date
12/07/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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