DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES

• K Number: K001814
• Device Name: DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES
• Manufacturer: DATEX-OHMEDA
• Date Cleared: 2000-08-23 ( 69 days)
• Product Code: CCK , BZK , BZL , CAP , CBQ , CBR , CBS , CCL
• Regulation Number: 868.1400
• Type: Abbreviated
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
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.(b)
Classification. Class II (performance standards).