RESPIRATORY HUMIDIFER

Humidifier, Respiratory Gas, (direct Patient Interface)

FISHER & PAYKEL HEALTHCARE, LTD.

The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Respiratory Humidifer.

Pre-market Notification Details

Device IDK110019
510k NumberK110019
Device Name:RESPIRATORY HUMIDIFER
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14348, PANMURE Auckland,  NZ 1741
ContactAdele Bindon
CorrespondentAdele Bindon
FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14348, PANMURE Auckland,  NZ 1741
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-03
Decision Date2012-03-30
Summary:summary

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