INFINITY ETCO2 + RESPIRATORY MECHANICS POD

• K Number: K003550
• Device Name: INFINITY ETCO2 + RESPIRATORY MECHANICS POD
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 2001-03-07 ( 110 days)
• Product Code: CCK
• Regulation Number: 868.1400
• Type: Traditional
• Panel: Anesthesiology
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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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).