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510(k) Data Aggregation

    K Number
    K010998
    Device Name
    LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
    Manufacturer
    LANGHAM OPHTHALMIC TECHNOLOGIES
    Date Cleared
    2001-06-27

    (85 days)

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

    LANGHAM OPHTHALMIC TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Langham Ocular Blood Flow (OBF) Model 201 measures the intraocular pressure and the pulse amplitude.
    Device Description
    Langham Ocular Blood Flow (OBF) Model 201 Tonograph/Tonometer
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