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 Humidifier.

Pre-market Notification Details

Device IDK945782
510k NumberK945782
Device Name:HUMIDIFIER
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
ContactRichard G Confer
CorrespondentRichard G Confer
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 Received1994-11-25
Decision Date1996-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00606959015210 K945782 000
00606959015203 K945782 000

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