CARBON DIOXIDE ANALYZER (MODEL CD-3A)

K942113 · Ametek, Inc. · CCK · Feb 16, 1995 · Anesthesiology

Device Facts

Record IDK942113
Device NameCARBON DIOXIDE ANALYZER (MODEL CD-3A)
ApplicantAmetek, Inc.
Product CodeCCK · Anesthesiology
Decision DateFeb 16, 1995
DecisionSESE
Submission TypeTraditional
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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