PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT

• K Number: K963956
• Device Name: PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT
• Manufacturer: SOUTHERN RESEARCH, INC.
• Date Cleared: 1996-12-09 ( 68 days)
• Product Code: BYJ
• Regulation Number: 868.5655
• 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

§ 868.5655 Portable liquid oxygen unit.

(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).