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

    PRONE POSITIONER

    K Number: K932187 · Decision Jun 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    0
    Applicant Total
    5
    Review Days
    27

    Basic Information

    Device Name
    PRONE POSITIONER
    K Number
    K932187
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    VOSS MEDICAL PRODUCTS
    Date Received
    May 5, 1993
    Decision Date
    June 1, 1993
    Product Code
    KIL
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KIL Positioner, Socket

    Other Clearances by VOSS MEDICAL PRODUCTS

    K Number Device Name
    K932186 BYPASS LEG POSITIONER
    K896338 VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA
    K885161 VOSS VEIN CLAMP
    K895369 VOSS GRAFT MARKER