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

    LAKEVILLE BODY VENTILATOR

    K Number: K840885 · Decision Jul 12, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    136

    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
    LAKEVILLE BODY VENTILATOR
    K Number
    K840885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5935
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Edwards Ventilator Co.
    Date Received
    February 27, 1984
    Decision Date
    July 12, 1984
    Product Code
    BYT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)

    Similar 510(k) Clearances

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

    RTX RESPIRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HAYEK OSCILLATOR(TM)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NEV-10 NEGATIVE PRESSURE VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM

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