RESPIRATORY HUMIDIFIER, MODEL # MR850

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 Humidifier, Model # Mr850.

Pre-market Notification Details

Device IDK983112
510k NumberK983112
Device Name:RESPIRATORY HUMIDIFIER, MODEL # MR850
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant FISHER & PAYKEL HEALTHCARE, LTD. HEALTHCARE DIV. 25 CARBINE RD. Auckland,  NZ
ContactChris Mander
CorrespondentChris Mander
FISHER & PAYKEL HEALTHCARE, LTD. HEALTHCARE DIV. 25 CARBINE RD. Auckland,  NZ
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-04
Decision Date1998-11-10
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.