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K Number
K082315
Device Name
EC50 MICRO+ SMOKERLYZER
Manufacturer
BEDFONT SCIENTIFIC LTD.
Date Cleared
2010-02-01

(537 days)

Product Code
CCJ,DLJ,LAS
Regulation Number
868.1430
Type
Traditional
Panel
TX
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.1430 Carbon monoxide gas analyzer.

(a)
Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.(b)
Classification. Class II (performance standards).