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

    THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER

    K Number: K901281 · Decision Aug 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    527

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    Basic Information

    Device Name
    THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER
    K Number
    K901281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1380
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Val-Mark Medical, Inc.
    Date Received
    March 19, 1990
    Decision Date
    August 28, 1991
    Product Code
    DRB
    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
    DRB Stylet, Catheter

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