WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER

Humidifier, Respiratory Gas, (direct Patient Interface)

MARQUEST MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Water Chambers For St 3000 Heated Humidifier.

Pre-market Notification Details

Device IDK962223
510k NumberK962223
Device Name:WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood,  CO  80112
ContactTom Dielmann
CorrespondentTom Dielmann
MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood,  CO  80112
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-10
Decision Date1997-01-14
Summary:summary

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