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510(k) K212031

F&P 850 AirSpiral Adult NIV and NHF Circuit Kit by Fisher &Paykel Healthcare , Ltd. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2022
Date Received
June 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

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