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

    90DX MULTITEST METER, MODIFICATION

    K Number: K925210 · Decision Jan 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    475

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    Basic Information

    Device Name
    90DX MULTITEST METER, MODIFICATION
    K Number
    K925210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mesa Medical, Inc.
    Date Received
    October 7, 1992
    Decision Date
    January 25, 1994
    Product Code
    FLB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLB Meter, Conductivity, Induction, Remote Type

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