BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable SpO2 Sensors, Reusable SpO2 Sensors

    K Number: K181270 · Decision Sep 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    5
    Review Days
    116

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    Basic Information

    Device Name
    Disposable SpO2 Sensors, Reusable SpO2 Sensors
    K Number
    K181270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orantech, Inc.
    Date Received
    May 14, 2018
    Decision Date
    September 7, 2018
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQA Oximeter

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    Other Clearances by Orantech, Inc.

    K Number Device Name
    K182327 Patient Cables and Leadwires , Disposable ECG Leadwires
    K173194 Temperature Probe
    K173197 Reusable NIBP Cuff
    K171828 ETCO2 Sensor