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FDA 510(k) Application Details - K050904
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
510(K) Number
K050904
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
15 MAURICE PAYKEL PLACE
EAST TAMAKI NZ
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Contact
JAMES THOMPSON
Other 510(k) Applications for this Contact
Regulation Number
868.5905
More FDA Info for this Regulation Number
Classification Product Code
BZD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/11/2005
Decision Date
05/25/2005
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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