DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

HUDSON RESPIRATORY CARE, INC.

The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Dual Lumen Oxygen Delivery Gas Sampling Cannula.

Pre-market Notification Details

Device IDK961150
510k NumberK961150
Device Name:DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. Temecula,  CA  92390 -0740
ContactArden Morley
CorrespondentArden Morley
HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. Temecula,  CA  92390 -0740
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-22
Decision Date1996-09-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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34026704744443 K961150 000

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