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

    CARDIOTOUCH-3000

    K Number: K023034 · Decision Nov 14, 2002
    View on FDA
    Classifications
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    82
    Applicant Total
    3
    Review Days
    63

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    Basic Information

    Device Name
    CARDIOTOUCH-3000
    K Number
    K023034
    Clearance Type
    Special
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bionet Company, Ltd.
    Date Received
    September 12, 2002
    Decision Date
    November 14, 2002
    Product Code
    LOS
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

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