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K Number
K954962
Device Name
SPACELABS MEDICAL MULTIGAS ANALYZER
Manufacturer
SPACELABS, INC.
Date Cleared
1996-05-31

(214 days)

Product Code
CBR
Regulation Number
868.1700
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.1700 Nitrous oxide gas analyzer.

(a)
Identification. A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.(b)
Classification. Class II (performance standards).