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

    RM Electrode (RMH 23-01)

    K Number: K232273 · Decision Dec 7, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    129

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    Basic Information

    Device Name
    RM Electrode (RMH 23-01)
    K Number
    K232273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1220
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Retmap, Inc.
    Date Received
    July 31, 2023
    Decision Date
    December 7, 2023
    Product Code
    HLZ
    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
    HLZ Electrode, Corneal

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    Other Clearances by Retmap, Inc.

    K Number Device Name
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