BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM)

    K Number: K944817 · Decision Nov 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    7
    Review Days
    41

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    Basic Information

    Device Name
    NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM)
    K Number
    K944817
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Msb , Ltd.
    Date Received
    September 29, 1994
    Decision Date
    November 9, 1994
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Msb , Ltd.

    K Number Device Name
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    K944496 BIOTRACE-N, NS, 410 AND RT
    K955261 NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION)
    K950587 ECOTABS
    K944260 ECG ELECTRODE