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

    ENTRAVISION EP-500 I/A ECCO PACK

    K Number: K862064 · Decision Jun 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    3
    Review Days
    20

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    Basic Information

    Device Name
    ENTRAVISION EP-500 I/A ECCO PACK
    K Number
    K862064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Entravision, Inc.
    Date Received
    May 30, 1986
    Decision Date
    June 19, 1986
    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 Entravision, Inc.

    K Number Device Name
    K870775 ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE
    K862063 ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE