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510(k) K153505

F&P Eson 2 Nasal Mask by Fisher & Paykel Healthcare Limited — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2016
Date Received
December 7, 2015
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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