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

    FOLEY CATHETER TEMPERATURE SENSOR

    K Number: K873448 · Decision Dec 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    27
    Review Days
    103

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    Basic Information

    Device Name
    FOLEY CATHETER TEMPERATURE SENSOR
    K Number
    K873448
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Respiratory Support Products, Inc.
    Date Received
    August 26, 1987
    Decision Date
    December 7, 1987
    Product Code
    KOD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KOD Catheter, Urological

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    Other Clearances by Respiratory Support Products, Inc.

    K Number Device Name
    K983862 CLOUD 1 HUMIDIFICATION SYSTEM
    K921190 ADAP-TEMP TEMPERATURE SENSOR ADAPTER
    K920469 MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE
    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
    K873472 MEMBRANE HUMIDIFIER
    Search all 27 clearances from Respiratory Support Products, Inc. →