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

    VENTILATOR CIRCUIT

    K Number: K812774 · Decision Oct 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    87
    Applicant Total
    33
    Review Days
    18

    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
    VENTILATOR CIRCUIT
    K Number
    K812774
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Hudson Oxygen Therapy Sales Co.
    Date Received
    October 5, 1981
    Decision Date
    October 23, 1981
    Product Code
    BZO
    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
    BZO Set, Tubing And Support, Ventilator (W Harness)

    Similar 510(k) Clearances

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

    UNICOR, INC. CORRUGATED TUBING

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    UNICOR, INC. VENTILATOR HOSES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA VENTILATOR HOSES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA CUSTOM ANESTESIA CIRCUIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA BREATHING BAGS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA VOLUMN VENTILATORSS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all

    Other Clearances by Hudson Oxygen Therapy Sales Co.

    K Number Device Name
    K902062 PEEP VALVE
    K900783 MDI ADAPTOR
    K900470 IN-THE NEBULIZER
    K895589 MANUAL RESUSCITATOR
    K896136 INFANT C.P.A.P. MONITOR
    K895231 CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
    K895747 VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR
    K890035 BACTERIA FILTER
    K870895 NO. 1552, VALVED VENTI-COMP
    K871157 C.P.A.P. NASAL CANNULA
    Search all 33 clearances from Hudson Oxygen Therapy Sales Co. →