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

    RAINCOAT

    K Number: K863910 · Decision Oct 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    87
    Applicant Total
    7
    Review Days
    12

    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
    RAINCOAT
    K Number
    K863910
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Artec Environmental Monitoring Division
    Date Received
    October 8, 1986
    Decision Date
    October 20, 1986
    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 Artec Environmental Monitoring Division

    K Number Device Name
    K900839 THE CAROLINA ROCKER
    K896886 ARTEC RESPOND PULMONARY RESUSCITATOR
    K873043 MOUTH TO FACE RESUSCITATOR
    K854573 ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE
    K832512 AIRWAY MASKS
    K830056 ARTEC TWIST VALVE