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FDA 510(k) Application Details - K170367
Device Classification Name
Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
More FDA Info for this Device
510(K) Number
K170367
Device Name
Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
Applicant
Fisher and Paykel Healthcare Limited
15 Maurice Paykel Place
Auckland 2013 NZ
Other 510(k) Applications for this Company
Contact
Danica Tung
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
MNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/06/2017
Decision Date
08/24/2017
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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