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

    ASPITRON

    K Number: K823088 · Decision Apr 6, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    6
    Review Days
    169

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    Basic Information

    Device Name
    ASPITRON
    K Number
    K823088
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Intl. Ophthalmic Industries Corp.
    Date Received
    October 19, 1982
    Decision Date
    April 6, 1983
    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 Intl. Ophthalmic Industries Corp.

    K Number Device Name
    K961658 MEGATRON OPHTHALMIC SURGICAL SYSTEM
    K894513 DIATHRON(R) DIATHERMY UNIT
    K894512 PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS
    K894511 MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT
    K791763 (MICRO-KERATRON, MICRO DUCT TREPHINE)