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

    ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T

    K Number: K864043 · Decision Dec 15, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    27
    Review Days
    60

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    Basic Information

    Device Name
    ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T
    K Number
    K864043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Respiratory Support Products, Inc.
    Date Received
    October 16, 1986
    Decision Date
    December 15, 1986
    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 Respiratory Support Products, Inc.

    K Number Device Name
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    K921510 GAS SAMPLING KIT MODIFICATION
    K913082 BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D
    K913083 BI-TEMP TEMPERATURE MONITOR TM-201D
    K912280 BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D
    K903816 URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
    K874694 ADAP-TEMP, MODEL: AT-100
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    Search all 27 clearances from Respiratory Support Products, Inc. →