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

    AVALON GENERAL PURPOSE SCANNER, PREVIEW GP

    K Number: K904317 · Decision Feb 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    2
    Review Days
    146

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    Basic Information

    Device Name
    AVALON GENERAL PURPOSE SCANNER, PREVIEW GP
    K Number
    K904317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Avalon Technology Corp.
    Date Received
    September 20, 1990
    Decision Date
    February 13, 1991
    Product Code
    DPW
    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
    DPW Flowmeter, Blood, Cardiovascular

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    Other Clearances by Avalon Technology Corp.

    K Number Device Name
    K895359 ADMS MULTIPLANE RECTAL PROBE