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

    TEMPERATURE PROBES

    K Number: K813271 · Decision Dec 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    41
    Applicant Total
    5
    Review Days
    39

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    Basic Information

    Device Name
    TEMPERATURE PROBES
    K Number
    K813271
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Webster Laboratories, Inc.
    Date Received
    November 20, 1981
    Decision Date
    December 29, 1981
    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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