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510(k) Data Aggregation

    K Number
    K160680
    Device Name
    VisioFocus Mini, VisioFocus Smart
    Manufacturer
    TECNIMED S.R.L.
    Date Cleared
    2017-04-19

    (405 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNIMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VisioFocus SMART and VisioFocus Mini are infrared thermometers intermittent measurement of human body temperature in people of all ages. This thermometer is for a measurement site of forehead.
    Device Description
    Not Found
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    K Number
    DEN130019
    Device Name
    ZANZA-CLICK
    Manufacturer
    TECNIMED S.R.L.
    Date Cleared
    2014-11-07

    (617 days)

    Product Code
    OSG
    Regulation Number
    882.5894
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNIMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zanza-Click (or Disc-o-Click, or Mini-Click) is indicated for temporarily reducing the swelling and itching caused by mosquito bites.
    Device Description
    The Zanza-Click (or Disc-o-Click, or Mini-Click) is a hand held device, consisting primarily of housing, a push button (which the user depresses to excite the piezoelectric crystal by means of a spring), a "Piezo unit" (containing piezoelectric crystal) and electrical output terminals (placed flush to the user's skin) intended to deliver electrical current to the skin.
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    K Number
    K122412
    Device Name
    VISIOFOCUS
    Manufacturer
    TECNIMED S.R.L.
    Date Cleared
    2013-03-13

    (217 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNIMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VisioFocus 06400, 06450, 06480 and 06490 series are infrared thermometers intended for intermittent measurement of human body temperature in people of all ages.
    Device Description
    Not Found
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    K Number
    K072108
    Device Name
    MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
    Manufacturer
    TECNIMED S.R.L.
    Date Cleared
    2007-08-31

    (30 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNIMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Thermofocus 0800, 0900, 01500, 0700 Series are infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages.
    Device Description
    Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are hand-held and battery-operated thermometers. They take skin temperature mainly in the middle of the forehead, on the navel, neck or under the armpit. The Thermofocus devices use the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Thermofocus thermometers take temperature at distance, without any contact with the patient.
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    K Number
    K033790
    Device Name
    THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
    Manufacturer
    TECNIMED S.R.L.
    Date Cleared
    2004-06-03

    (182 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECNIMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermotocus series 0800, 01500 and 0700 are infrared thermometers intended for the intermittent measurement of human body temperature of people of all ages
    Device Description
    Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. In case of difficult to take the temperature on this area it is also possible to take the temperature on the navel or under the armpit. The Thermofocus devices use the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Thanks to an exclusive optic aiming system, the peculiarity of Thermofocus thermometers is to take the temperature at distance, without any contact with the patient.
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