100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I

• K Number: K010382
• Device Name: 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
• Manufacturer: SENSIDYNE, INC.
• Date Cleared: 2001-03-01 ( 21 days)
• Product Code: CCL
• Regulation Number: 868.1720
• Type: Special
• Panel: Anesthesiology
• 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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Regulation Number and Section

§ 868.1720 Oxygen gas analyzer.

(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).