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

    YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES

    K Number: K922821 · Decision Nov 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    23
    Review Days
    165

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    Basic Information

    Device Name
    YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES
    K Number
    K922821
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Yellow Springs Instrument Co., Inc.
    Date Received
    June 11, 1992
    Decision Date
    November 23, 1992
    Product Code
    EZL
    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
    EZL Catheter, Retention Type, Balloon

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    Other Clearances by Yellow Springs Instrument Co., Inc.

    K Number Device Name
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    K910633 YSI MODEL 1500 BLOOD GLUCOSE ANALYZER
    K910718 YSI PRECISION 4000 THERMOMETER
    K901131 YSI MODEL 1500 SPORT L-LACTATE ANALYZER
    K893409 YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
    K891480 YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER
    K883793 DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)
    K865012 YSI MODEL 801
    K853551 YSI MODEL 790 TELE-THERMOMETER
    Search all 23 clearances from Yellow Springs Instrument Co., Inc. →