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

    ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK

    K Number: K884386 · Decision Jan 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    79

    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
    ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK
    K Number
    K884386
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1140
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ethitek Pharmaceuticals Co.
    Date Received
    October 18, 1988
    Decision Date
    January 5, 1989
    Product Code
    KRK
    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
    KRK Manometer, Blood-Pressure, Venous

    Similar 510(k) Clearances

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

    UST-5268P-5 TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CENTRAL VENOUS PRESSURE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCHNEIDER-SHILEY PRESSURE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MANOMETER SET C.V.P. #S 298/299

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDIFIX

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