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

    STETHOSCOPE WITH TEMPERATURE SENSOR

    K Number: K791190 · Decision Jul 6, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    8
    Review Days
    10

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    Basic Information

    Device Name
    STETHOSCOPE WITH TEMPERATURE SENSOR
    K Number
    K791190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    National Catheter Co. Div. Mallinckrodt
    Date Received
    June 26, 1979
    Decision Date
    July 6, 1979
    Product Code
    BZT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BZT Stethoscope, Esophageal, With Electrical Conductors

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    Other Clearances by National Catheter Co. Div. Mallinckrodt

    K Number Device Name
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    K810321 REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)
    K801924 HI-LO TEMP GEN. PURPOSE TEMP. PROBE
    K801005 MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)
    K781665 TUBE, LEATHERMAN/IMBRUCE
    K770727 MANIPULATOR & INJECTOR, UTERINE