MICROSTREAM ORAL NASAL CANNULA FILTERLINE

K011050 · Oridion Medical 1987 , Ltd. · CCK · May 4, 2001 · Anesthesiology

Device Facts

Record IDK011050
Device NameMICROSTREAM ORAL NASAL CANNULA FILTERLINE
ApplicantOridion Medical 1987 , Ltd.
Product CodeCCK · Anesthesiology
Decision DateMay 4, 2001
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 868.1400
Device ClassClass 2

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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