HVT 2.0

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 Hvt 2.0.

Pre-market Notification Details

Device IDK203357
510k NumberK203357
Device Name:HVT 2.0
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant Vapotherm Inc. 100 Domain Drive Exeter,  NH  03833
ContactDennis Francoeur
CorrespondentDennis Francoeur
Vapotherm Inc. 100 Domain Drive Exeter,  NH  03833
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-16
Decision Date2021-08-25

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