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

    MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR

    K Number: K874525 · Decision Jan 6, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    17
    Review Days
    65

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    Basic Information

    Device Name
    MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR
    K Number
    K874525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mon-A-Therm, Inc.
    Date Received
    November 2, 1987
    Decision Date
    January 6, 1988
    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 Mon-A-Therm, Inc.

    K Number Device Name
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    K875234 MON-A-THERM'S SKIN TEMPERATURE SENSOR
    K874524 MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR
    K874523 MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR
    K874521 MODIFIED THERMAL WELL TEMPERATURE SENSOR
    K874520 MODIFIED AIRWAY TEMPERATURE SENSOR
    K853392 MON-A-THERM SUBCUTANEOUS TEMP. SENSOR
    K830819 MODIFICATION ELECTRONIC CLINICAL THERMO-
    Search all 17 clearances from Mon-A-Therm, Inc. →