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

    MEPA-1 BLOOD ANALYZER

    K Number: K781606 · Decision Oct 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    56
    Applicant Total
    1
    Review Days
    15

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    Basic Information

    Device Name
    MEPA-1 BLOOD ANALYZER
    K Number
    K781606
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medico Electronic, Inc.
    Date Received
    September 18, 1978
    Decision Date
    October 3, 1978
    Product Code
    JJF
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JJF Analyzer, Chemistry, Micro, For Clinical Use

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