OASIS HUMIDIFIER

Humidifier, Respiratory Gas, (direct Patient Interface)

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Oasis Humidifier.

Pre-market Notification Details

Device IDK964653
510k NumberK964653
Device Name:OASIS HUMIDIFIER
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
ContactFrancis X Dobscha
CorrespondentFrancis X Dobscha
RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-20
Decision Date1997-02-14
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.