Vapotherm Aerosol Adapter AAA-2

Nebulizer (direct Patient Interface)

Vapotherm Inc.

The following data is part of a premarket notification filed by Vapotherm Inc. with the FDA for Vapotherm Aerosol Adapter Aaa-2.

Pre-market Notification Details

Device IDK220869
510k NumberK220869
Device Name:Vapotherm Aerosol Adapter AAA-2
ClassificationNebulizer (direct Patient Interface)
Applicant Vapotherm Inc. 100 Domain Drive Exeter,  NH  03833
ContactMichael J. Webb
CorrespondentMichael J. Webb
Vapotherm Inc. 100 Domain Drive Exeter,  NH  03833
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-25
Decision Date2022-10-28

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