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FDA 510(k) Application Details - K211560
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K211560
Device Name
Nebulizer (Direct Patient Interface)
Applicant
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place, East Tamaki
Auckland 2013 NZ
Other 510(k) Applications for this Company
Contact
Reena Daken
Other 510(k) Applications for this Contact
Regulation Number
868.5630
More FDA Info for this Regulation Number
Classification Product Code
CAF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/20/2021
Decision Date
12/10/2021
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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