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FDA 510(k) Application Details - K110019
Device Classification Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K110019
Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
P.O. BOX 14348, PANMURE
AUCKLAND 1741 NZ
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Contact
ADELE BINDON
Other 510(k) Applications for this Contact
Regulation Number
868.5450
More FDA Info for this Regulation Number
Classification Product Code
BTT
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More FDA Info for this Product Code
Date Received
01/03/2011
Decision Date
03/30/2012
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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