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

    DGH MODEL 9000

    K Number: K965127 · Decision Mar 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    DGH MODEL 9000
    K Number
    K965127
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dgh Technology, Inc.
    Date Received
    December 23, 1996
    Decision Date
    March 17, 1997
    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 Dgh Technology, Inc.

    K Number Device Name
    K171301 Scanmate Flex
    K093371 MODEL DGH 6000 SCANMATE A
    K033385 DGH 55 HANDHELD PACHYMETER (PACHMATE)
    K920906 DGH-500 PACHYMETER
    K913067 DGH-4000 A-SCAN/PACHYMETER
    K872726 DGH-3000A A-SCAN