HUMIDIFIER-CASCADE II

Humidifier, Respiratory Gas, (direct Patient Interface)

PURITAN BENNETT CORP.

The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Humidifier-cascade Ii.

Pre-market Notification Details

Device IDK760923
510k NumberK760923
Device Name:HUMIDIFIER-CASCADE II
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant PURITAN BENNETT CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-10-28
Decision Date1976-11-19

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