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510(k) K120027

PILAIRO NASAL PILLOWS MASK by Fisher & Paykel Healthcare Limited — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2012
Date Received
January 3, 2012
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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  • K153505 — F&P Eson 2 Nasal Mask (September 20, 2016)
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