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

    TMO INTEGRATED CIRCUIT SYSTEM

    K Number: K820406 · Decision Mar 2, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    41
    Applicant Total
    206
    Review Days
    18

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    Basic Information

    Device Name
    TMO INTEGRATED CIRCUIT SYSTEM
    K Number
    K820406
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    February 12, 1982
    Decision Date
    March 2, 1982
    Product Code
    KRI
    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
    KRI Accessory Equipment, Cardiopulmonary Bypass

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