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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    TES-20

    K Number: K992425 · Decision Oct 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    TES-20
    K Number
    K992425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tes Electrical Electronic Corp.
    Date Received
    July 21, 1999
    Decision Date
    October 19, 1999
    Product Code
    MWJ
    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
    MWJ Electrocardiograph, Ambulatory (Without Analysis)

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