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510(k) Data Aggregation

    K Number
    K131711
    Device Name
    YZ3 PORTABLE SLIT LAMP
    Manufacturer
    SUZHOU 66 VISION TECH CO., LTD.
    Date Cleared
    2014-05-09

    (332 days)

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

    SUZHOU 66 VISION TECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YZ3 Portable Slit Lamp is intended for use in the examination of the anterior segment of the eye.
    Device Description
    Not Found
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    K Number
    K052599
    Device Name
    66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
    Manufacturer
    SUZHOU 66 VISION TECH CO., LTD.
    Date Cleared
    2006-11-07

    (412 days)

    Product Code
    HLJ
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUZHOU 66 VISION TECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 66 Vision Tech Ophthalmoscopes (Indirect and Direct) are intended to examine the cornea, aqueous, lens and vitreous and the retina of the eye.
    Device Description
    Not Found
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