F&P SIMPLUS FULL FACE 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 F&p Simplus Full Face Mask.

Pre-market Notification Details

Device IDK130328
510k NumberK130328
Device Name:F&P SIMPLUS FULL FACE MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant FISHER & PAYKEL HEALTHCARE LIMITED 15 MAURICE PAYKEL PLACE EAST TAMAKI Auckland,  NZ 2013
ContactSue Cho
CorrespondentSue Cho
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 Received2013-02-11
Decision Date2013-06-05
Summary:summary

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