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

    HI-LO TEMP ESOPHAGEAL STETHOSCOPE

    K Number: K811862 · Decision Jul 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    92
    Review Days
    9

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    Basic Information

    Device Name
    HI-LO TEMP ESOPHAGEAL STETHOSCOPE
    K Number
    K811862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Mallinckrodt Critical Care
    Date Received
    July 1, 1981
    Decision Date
    July 10, 1981
    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 Mallinckrodt Critical Care

    K Number Device Name
    K880343 BURNEY GALLBLADDER CATHETER KIT
    K874605 HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
    K874514 HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
    K874568 HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
    K874404 HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
    K873461 LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
    K873833 THERMOCOUPLE ADAPTER
    K873004 GUIDING CATHETER
    K871204 CUFFED TRACHEAL TUBE (MULTIPLE)
    K862666 UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
    Search all 92 clearances from Mallinckrodt Critical Care →