BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ARUBI FLATTER & ARUBI FLATTER-S

    K Number: K831206 · Decision Jun 2, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    759
    Registration Numbers
    759
    Same Product Code
    99
    Applicant Total
    1
    Review Days
    50

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    Basic Information

    Device Name
    ARUBI FLATTER & ARUBI FLATTER-S
    K Number
    K831206
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Kc Export Management Co.
    Date Received
    April 13, 1983
    Decision Date
    June 2, 1983
    Product Code
    ISA
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ISA Massager, Therapeutic, Electric

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