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510(k) K173060

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version by Fisher and Paykel Healthcare Limited — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2018
Date Received
September 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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