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

    YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP

    K Number: K893409 · Decision Jul 20, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    23
    Review Days
    71

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    Basic Information

    Device Name
    YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP
    K Number
    K893409
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1920
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Yellow Springs Instrument Co., Inc.
    Date Received
    May 10, 1989
    Decision Date
    July 20, 1989
    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 Yellow Springs Instrument Co., Inc.

    K Number Device Name
    K962070 YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE
    K922821 YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES
    K922007 YSI MODEL 441A AIRWAY TEMPERATURE PROBE
    K910633 YSI MODEL 1500 BLOOD GLUCOSE ANALYZER
    K910718 YSI PRECISION 4000 THERMOMETER
    K901131 YSI MODEL 1500 SPORT L-LACTATE ANALYZER
    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. →