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

    CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420

    K Number: K896971 · Decision Feb 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    29
    Applicant Total
    8
    Review Days
    54

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    Basic Information

    Device Name
    CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420
    K Number
    K896971
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Daily Medical Products, Inc.
    Date Received
    December 13, 1989
    Decision Date
    February 5, 1990
    Product Code
    DWC
    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
    DWC Controller, Temperature, Cardiopulmonary Bypass

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    Other Clearances by Daily Medical Products, Inc.

    K Number Device Name
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    K905652 MYOCARDIAL TEMPERATURE MONITORING PROBES, CJ-1000
    K905568 TOPICAL COOLING PAD, MODEL 7000
    K896972 CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520
    K896975 CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220
    K896974 CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120
    K896973 CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320