BREAS HA50 HUMIDIFIER, MODEL HA50

Humidifier, Respiratory Gas, (direct Patient Interface)

VITAL SIGNS, INC.

The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Breas Ha50 Humidifier, Model Ha50.

Pre-market Notification Details

Device IDK002454
510k NumberK002454
Device Name:BREAS HA50 HUMIDIFIER, MODEL HA50
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant VITAL SIGNS, INC. 11039 EAST LANSING CIRCLE Englewood,  CO 
ContactThomas W Dielmann
CorrespondentThomas W Dielmann
VITAL SIGNS, INC. 11039 EAST LANSING CIRCLE Englewood,  CO 
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-10
Decision Date2001-03-07

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