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    K Number
    K973282
    Device Name
    HANDI OXYGEN ANALYZER
    Manufacturer
    CERAMATEC, INC.
    Date Cleared
    1998-03-04

    (183 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K935370
    Why did this record match?
    Device Name :

    HANDI OXYGEN ANALYZER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Ceramatec® Handi oxygen analyzer is to monitor the oxygen concentration in the patient-breathing environment.

    Device Description

    The Ceramated Handi oxygen analyzer is comprised of a galvanic oxygen sensor and an analyzer module. The galvanic oxygen sensor produces a millivolt output that is proportional to the partial pressure of oxygen in the monitored gas. The analyzer module contains an electronic circuit that converts the millivolt output of the sensor to a digital percent-oxygen reading on a liquid-crystal display (LCD).

    AI/ML Overview

    Here's an analysis of the Ceramatec Handi Oxygen Analyzer based on the provided text, focusing on acceptance criteria and the study that proves its adherence:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the Ceramatec Handi Oxygen Analyzer are implicitly established by demonstrating substantial equivalence to a legally marketed predicate device, the MSA Miniox® IA oxygen analyzer. The device performance is then compared against these criteria, which are the specifications of the predicate device.

    Acceptance Criteria (Predicate Device Specification - MSA Miniox® IA)Reported Device Performance (Ceramatec® Handi)
    Display Range: 0-100% oxygenDisplay Range: 0-99% oxygen
    Display Resolution: 0.1% oxygenDisplay Resolution: 1% oxygen
    Warm-up time: none requiredWarm-up time: none required
    Operating Temperature Range: 0 - 40°COperating Temperature Range: 10 - 40°C
    Operating Humidity Range: 0-95% RH non-condensingOperating Humidity Range: 0-95% RH non-condensing
    Accuracy: ±3% full-scaleAccuracy: ±3% full-scale
    Linearity: ±2% full-scaleLinearity: ±2% full-scale
    Sensor type: galvanic fuel sensor 0-100% O2Sensor type: galvanic fuel sensor 0-100% O2
    Sensor Operating Life: 12 months under normal operating conditionsSensor Operating Life: 12 months under normal operating conditions
    Sensor Shelf Life: 6 monthsSensor Shelf Life: 6 months
    Storage Temperature: -20 - 55 °CStorage Temperature: -15° - 50 °C
    90% FS Response Time:
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