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

    YSI MODEL 801

    K Number: K865012 · Decision Mar 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    91
    Applicant Total
    23
    Review Days
    71

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    Basic Information

    Device Name
    YSI MODEL 801
    K Number
    K865012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5130
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Yellow Springs Instrument Co., Inc.
    Date Received
    December 23, 1986
    Decision Date
    March 4, 1987
    Product Code
    FMT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMT Warmer, Infant Radiant

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    Other Clearances by Yellow Springs Instrument Co., Inc.

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