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

    KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263

    K Number: K862261 · Decision Feb 19, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    176
    Applicant Total
    57
    Review Days
    251

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    Basic Information

    Device Name
    KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263
    K Number
    K862261
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Kontron Instruments, Inc.
    Date Received
    June 13, 1986
    Decision Date
    February 19, 1987
    Product Code
    DXG
    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
    DXG Computer, Diagnostic, Pre-Programmed, Single-Function

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