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

    SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE

    K Number: K101244 · Decision Nov 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    2
    Review Days
    198

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    Basic Information

    Device Name
    SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE
    K Number
    K101244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Truer Medical, Inc.
    Date Received
    May 4, 2010
    Decision Date
    November 18, 2010
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    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 Truer Medical, Inc.

    K Number Device Name
    K092716 ESOPHAGEAL STETHOSCOPE