MEMBRANE HUMIDIFIER

Humidifier, Respiratory Gas, (direct Patient Interface)

RESPIRATORY SUPPORT PRODUCTS, INC.

The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Membrane Humidifier.

Pre-market Notification Details

Device IDK873472
510k NumberK873472
Device Name:MEMBRANE HUMIDIFIER
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa,  CA  92626
ContactAnthony V Beran
CorrespondentAnthony V Beran
RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa,  CA  92626
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-28
Decision Date1988-01-19

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