BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    VISION CARE/PHAKOSYSTEMS ECHORULE

    K Number: K871938 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    5
    Review Days
    189

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    Basic Information

    Device Name
    VISION CARE/PHAKOSYSTEMS ECHORULE
    K Number
    K871938
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Phakosystems, Inc.
    Date Received
    May 18, 1987
    Decision Date
    November 23, 1987
    Product Code
    IYO
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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    Other Clearances by Phakosystems, Inc.

    K Number Device Name
    K880081 VISION CARE/PHAKOSYSTEMS ECHOPACH
    K860236 PHAKOSYSTEMS CT-100 CAUTERY MODULE
    K851674 PHAKOSYSTEMS MODEL CES 4100
    K830871 PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION