BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116

    K Number: K013133 · Decision Nov 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    55

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    Basic Information

    Device Name
    NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
    K Number
    K013133
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nordix, Inc.
    Date Received
    September 19, 2001
    Decision Date
    November 13, 2001
    Product Code
    MOQ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MOQ Battery, Replacement, Rechargeable

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