LUNG DIFFUSION GAS MIXTURES

Gas, Calibration (specified Concentration)

NORCO, INC.

The following data is part of a premarket notification filed by Norco, Inc. with the FDA for Lung Diffusion Gas Mixtures.

Pre-market Notification Details

Device IDK911471
510k NumberK911471
Device Name:LUNG DIFFUSION GAS MIXTURES
ClassificationGas, Calibration (specified Concentration)
Applicant NORCO, INC. 1121 WEST AMITY Boise,  ID  83705
ContactLyle R Feely
CorrespondentLyle R Feely
NORCO, INC. 1121 WEST AMITY Boise,  ID  83705
Product CodeBXK  
CFR Regulation Number868.6400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-03
Decision Date1991-06-18

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