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

    TOPICAL COOLING PAD, MODEL 7000

    K Number: K905568 · Decision Jan 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    8
    Review Days
    42

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    Basic Information

    Device Name
    TOPICAL COOLING PAD, MODEL 7000
    K Number
    K905568
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Daily Medical Products, Inc.
    Date Received
    December 12, 1990
    Decision Date
    January 23, 1991
    Product Code
    DTR
    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
    DTR Heat-Exchanger, Cardiopulmonary Bypass

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    Other Clearances by Daily Medical Products, Inc.

    K Number Device Name
    K914005 FIBEROPTIC TYMPANIC THERMOMETER, MODEL 6000
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    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
    K896971 CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420