BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HALL ARTERIAL OSCILLATOR

    K Number: K801063 · Decision Sep 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    13
    Applicant Total
    36
    Review Days
    143

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    Basic Information

    Device Name
    HALL ARTERIAL OSCILLATOR
    K Number
    K801063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Sterilizer Co.
    Date Received
    May 6, 1980
    Decision Date
    September 26, 1980
    Product Code
    DWX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWX Stripper, Artery, Intraluminal

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