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

    MD-1A GALVANIC UNIT

    K Number: K964208 · Decision Apr 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    72
    Applicant Total
    13
    Review Days
    208

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    Basic Information

    Device Name
    MD-1A GALVANIC UNIT
    K Number
    K964208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    R. A. Fischer Co. Corp.
    Date Received
    October 4, 1996
    Decision Date
    April 30, 1997
    Product Code
    EGJ
    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
    EGJ Device, Iontophoresis, Other Uses

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