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K Number
K032143
Device Name
LIQUID OXYGEN SYSTEM
Manufacturer
MICRO TECHNOLOGY SERVICES, INC.
Date Cleared
2004-03-30

(260 days)

Product Code
BYJ
Regulation Number
868.5655
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LOX-Stat electronic contents gauge is intended for use with the Puritan Bennett companion 21/31/41 Liquid Oxygen Reservoirs to digitally display the liquid oxygen content remaining in the tank.

Device Description

LOX-Stat Liquid Oxygen Reservoir Content Gauge

AI/ML Overview

This is a letter for a 510(k) premarket notification for a medical device called "LOX-Stat Liquid Oxygen Reservoir Content Gauge". It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The document does not contain the requested information regarding acceptance criteria, device performance results, study details (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone), or training set information. It is a regulatory clearance letter, not a study report.

§ 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).