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510(k) Data Aggregation

    K Number
    K003332
    Device Name
    MEDITHERM MED2000
    Manufacturer
    MEDITHERM, INC.
    Date Cleared
    2001-02-21

    (120 days)

    Product Code
    LHQ
    Regulation Number
    884.2980
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDITHERM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Meditherm med2000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body in the clinical, hospital, healthcare practitioner facilities or in any environment when healthcares were with acute care settings, surgery, healthcare applications. The Meditherm med2000 provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display. Use of this device is determined by the healthcare professional and is based upon his or her assessment of the patient's medical condition and requirements. The patient populations and many of the populations include all ages of the human body and internal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use.
    Device Description
    The Meditherm med2000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body. It provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display.
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