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    K Number
    K970605
    Device Name
    3-CCD DIGITAL CAMERA
    Manufacturer
    ENVISION MEDICAL CORP.
    Date Cleared
    1997-05-22

    (93 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENVISION MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3-CCD Digital Camera System provides medical professionals with video capabilities for diagnostic and surgical procedures.
    Device Description
    This device is a 3-CCD Digital Camera System utilized for medical applications. The intended use for this device is identical to that of most contemporary surgical video camera systems and accessories. The 3-CCD Digital Camera System has been designed and manufactured to meet the UL 2601.1, IEC 601-1, CAN/CSA 601.1, and EN 60601 guidelines for electrical safety.
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