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

    KEELER CRYO MASTER & PROBES

    K Number: K992954 · Decision Dec 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    9
    Applicant Total
    60
    Review Days
    111

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    Basic Information

    Device Name
    KEELER CRYO MASTER & PROBES
    K Number
    K992954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4170
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Keeler Instruments, Inc.
    Date Received
    September 1, 1999
    Decision Date
    December 21, 1999
    Product Code
    HRN
    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
    HRN Unit, Cryophthalmic, Ac-Powered

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