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

    DI-RHEX OPHTHALMIC DIATHERMY SYSTEM

    K Number: K990064 · Decision Apr 4, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    10
    Applicant Total
    9
    Review Days
    86

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    Basic Information

    Device Name
    DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
    K Number
    K990064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4100
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ophthalmic Technologies, Inc.
    Date Received
    January 8, 1999
    Decision Date
    April 4, 1999
    Product Code
    HQR
    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
    HQR Apparatus, Cautery, Radiofrequency, Ac-Powered

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