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510(k) Data Aggregation

    K Number
    K053425
    Device Name
    PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
    Manufacturer
    PRECISION OPTICS CORP.
    Date Cleared
    2006-01-09

    (32 days)

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

    PRECISION OPTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vidco Ophthalmoscope is intended to be used by trained personnel to examine the cornea, aqueous, lens, vitreous, and retina of the eye.
    Device Description
    The Precision Optics Corporation Video Ophthalmoscope is a hand held indirect and direct monocular device for use by trained personnel for viewing / examining the cornea, agueous, lens, vitreous, and retina of the patient's eye(s). The viewing path is split in two via a beamsplitter to provide for direct viewing by the trained personnel as well as simultaneous video imaging on a monitor either near or at the patient or at a remote site via telemedicine techniques. The viewing system is comprised of objective lenses, relays, a beamsplitter, and eyepiece and provides an erect, un-reversed image of the patient's retina to the trained personnel.
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    K Number
    K983123
    Device Name
    POC ENT ENDOSCOPE - SINUSCOPE
    Manufacturer
    PRECISION OPTICS CORP.
    Date Cleared
    1998-09-25

    (86 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION OPTICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Precision Optics Corporation's ENT Endoscopes - Sinuscopes are indicated for use to mination and visualization of these regions.
    Device Description
    ENT Endoscope - Sinuscope
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