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510(k) Data Aggregation

    K Number
    K032967
    Device Name
    PASCAL DYNAMIC CONTOUR TONOMETER
    Manufacturer
    SMT SWISS MICROTECHNOLOGY AG
    Date Cleared
    2003-11-14

    (52 days)

    Product Code
    HKY
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMT SWISS MICROTECHNOLOGY AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PASCAL™ Dynamic Contour Tonometer is a diagnostic device that serves for measuring intraocular pressure (IOP), according to the Contour Tonometry method. The device is also capable of measuring short term pressure fluctuations. PASCAL™ is specially indicated in Glaucoma.
    Device Description
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