BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent for Some Indications 🇺🇸 United States

    EMS I.V. START KIT

    K Number: K951167 · Decision May 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    29
    Applicant Total
    1
    Review Days
    63

    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
    EMS I.V. START KIT
    K Number
    K951167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Emergency Medical Supply, Inc.
    Date Received
    March 14, 1995
    Decision Date
    May 16, 1995
    Product Code
    LRS
    Advisory Committee
    General Hospital
    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
    LRS I.V. Start Kit

    Similar 510(k) Clearances

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

    AMSINO I.V. START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INFUSION IV SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IV START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    B. BRAUN IV START KITS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PERSONAL HEARING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SAFESTART VASCULAR ACCESS START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all