BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇴 Norway

    Reusable Full Silicone Cover

    K Number: K151702 · Decision Aug 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    16
    Applicant Total
    5
    Review Days
    50

    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
    Reusable Full Silicone Cover
    K Number
    K151702
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Laerdal Medical AS
    Date Received
    June 24, 2015
    Decision Date
    August 13, 2015
    Product Code
    LIX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LIX Aid, Cardiopulmonary Resuscitation

    Similar 510(k) Clearances

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

    CPR BAND

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Reusable Silicone Cover CPRmeter 2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CPRmeter 2 CPR Feedback Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CPR RSQ ASSIST

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRUECPR COACHING DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CPRMETER CPR FEEDBACK DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Laerdal Medical AS

    K Number Device Name
    K251631 The BAG manual resuscitator and accessories
    K232111 NeoBeat, NeoBeat Mini
    K183348 Reusable Silicone Cover CPRmeter 2
    K173886 CPRmeter 2 CPR Feedback Device