THERASTEAM PERSONAL STEAM INHALER

Humidifier, Non-direct Patient Interface (home-use)

KAZ, INC.

The following data is part of a premarket notification filed by Kaz, Inc. with the FDA for Therasteam Personal Steam Inhaler.

Pre-market Notification Details

Device IDK950116
510k NumberK950116
Device Name:THERASTEAM PERSONAL STEAM INHALER
ClassificationHumidifier, Non-direct Patient Interface (home-use)
Applicant KAZ, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington,  DC  20004 -1109
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
KAZ, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington,  DC  20004 -1109
Product CodeKFZ  
CFR Regulation Number868.5460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-11
Decision Date1995-02-10

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