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510(k) Data Aggregation

    K Number
    K081756
    Device Name
    OCULAR RESPONSE ANALYZER
    Manufacturer
    REICHERT INC.
    Date Cleared
    2008-08-07

    (48 days)

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

    REICHERT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ocular Response Analyzer is intended to measure intra-ocular pressure of the eye and biomechanical response of the cornea.
    Device Description
    Not Found
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    K Number
    K063750
    Device Name
    XCEL 255 SLIT LAMP
    Manufacturer
    REICHERT INC.
    Date Cleared
    2006-12-20

    (1 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    REICHERT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An AC-Powered slitlamp biomicroscope is intended for use in eye examination of the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
    Device Description
    Not Found
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    K Number
    K042831
    Device Name
    ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)
    Manufacturer
    REICHERT INC.
    Date Cleared
    2004-10-28

    (15 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    REICHERT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ATP is intended to measure intra-ocular pressure and comeal thickness of the eye for the purpose of aiding in the diagnosis and monitoring of glaucoma.
    Device Description
    Not Found
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    K Number
    K032799
    Device Name
    NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
    Manufacturer
    REICHERT INC.
    Date Cleared
    2004-01-20

    (133 days)

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

    REICHERT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORA is intended to measure intra-ocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma.
    Device Description
    Not Found
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