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

    ESOPHAGEAL PROBE W/TEMP. INDICATOR

    K Number: K830353 · Decision Apr 6, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    9
    Review Days
    62

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    Basic Information

    Device Name
    ESOPHAGEAL PROBE W/TEMP. INDICATOR
    K Number
    K830353
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Science Development Corp.
    Date Received
    February 3, 1983
    Decision Date
    April 6, 1983
    Product Code
    FLL
    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
    FLL Continuous Measurement Thermometer

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    Other Clearances by Science Development Corp.

    K Number Device Name
    K843617 SDC SILICONE SUMP DRAIN
    K842491 SDC SILICONE FORCEP SHODS PRODUCT
    K833355 SDC VASCULAR TIES
    K832090 SCD SKIN TEMP. SENSORS #3400 ETC
    K832391 QT-100 ELECTRONIC TEMP. MONITOR
    K832392 SDC ORAL-RECTAL TEMP. PROBE
    K830329 ESOPHAGEAL STETHOSCOPE
    K830039 SDC RECTAL TEMP. PROBE PRODUCT #1020