Palladium High Flow Therapy System

Humidifier, Respiratory Gas, (direct Patient Interface)

Vapotherm, Inc.

The following data is part of a premarket notification filed by Vapotherm, Inc. with the FDA for Palladium High Flow Therapy System.

Pre-market Notification Details

Device IDK191010
510k NumberK191010
Device Name:Palladium High Flow Therapy System
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant Vapotherm, Inc. 100 Domain Drive Exeter,  NH  03833
ContactRichelle Helman
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 Received2019-04-16
Decision Date2019-10-10
Summary:summary

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