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

    NEVOSCOPE

    K Number: K954943 · Decision Mar 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    36
    Applicant Total
    1
    Review Days
    149

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NEVOSCOPE
    K Number
    K954943
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6320
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nizar A. Mullani
    Date Received
    October 30, 1995
    Decision Date
    March 27, 1996
    Product Code
    KZF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZF Device, Medical Examination, Ac Powered

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KZF), ordered by most recent decision date.

    WELCH ALLYN VIDEO EPISCOPE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    H 5100, H 5200, H 5300

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG

    FDA 510(k)
    FDA Class 1 ·General Hospital

    WAVE FLUORESCENT MAGNIFIER

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SKYTRON EXAM LIGHT

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all