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510(k) K212371

F&P Evora Full Face Mask by Fisher &Paykel Healthcare , Ltd. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2022
Date Received
July 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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