PILAIRO NASAL PILLOWS MASK

Ventilator, Non-continuous (respirator)

FISHER & PAYKEL HEALTHCARE LIMITED

The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Limited with the FDA for Pilairo Nasal Pillows Mask.

Pre-market Notification Details

Device IDK120027
510k NumberK120027
Device Name:PILAIRO NASAL PILLOWS MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant FISHER & PAYKEL HEALTHCARE LIMITED 15 MAURICE PAYKEL PLACE EAST TAMAKI Auckland,  NZ 2013
ContactTina Mason
CorrespondentTina Mason
FISHER & PAYKEL HEALTHCARE LIMITED 15 MAURICE PAYKEL PLACE EAST TAMAKI Auckland,  NZ 2013
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-03
Decision Date2012-02-23
Summary:summary

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