TNI SoftFlow 50

Humidifier, Respiratory Gas, (direct Patient Interface)

TNI Medical AG

The following data is part of a premarket notification filed by Tni Medical Ag with the FDA for Tni Softflow 50.

Pre-market Notification Details

Device IDK180474
510k NumberK180474
Device Name:TNI SoftFlow 50
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant TNI Medical AG Hofmannstr. 8 Wuerzburg,  DE 97084
ContactJoseph P. Mcmenamin
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2018-02-22
Decision Date2018-10-18

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