BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000

    K Number: K901686 · Decision Jun 8, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    77
    Review Days
    57

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    Basic Information

    Device Name
    NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000
    K Number
    K901686
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Nidek, Inc.
    Date Received
    April 12, 1990
    Decision Date
    June 8, 1990
    Product Code
    HQC
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQC Unit, Phacofragmentation

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    Other Clearances by Nidek, Inc.

    K Number Device Name
    K050336 OPD-STATION SOFTWARE
    K042785 MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
    K031733 NON-CONTACT TONOMETER, MODEL NT-4000
    K032085 GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
    K013694 NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
    K020876 ECHOSCAN, MODEL US-1800
    K014274 NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
    K013760 DC-3300 LASER DIODE PHOTOCOAGULATOR
    K013864 MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
    K990119 EPI-STAR SURGICAL LASER SYSTER
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