BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇱 Israel

    PMD-200

    K Number: DEN210022 · Decision Feb 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    623

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    Basic Information

    Device Name
    PMD-200
    K Number
    DEN210022
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    868.2200
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Applicant
    Medasense Biometrics , Ltd.
    Date Received
    June 4, 2021
    Decision Date
    February 17, 2023
    Product Code
    QVE
    Advisory Committee
    Anesthesiology
    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
    QVE Adjunctive Pain Measurement Device For Anesthesiology