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

    PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS

    K Number: K863033 · Decision Aug 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    87
    Applicant Total
    10
    Review Days
    9

    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
    PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS
    K Number
    K863033
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Intertech/Ohio
    Date Received
    August 11, 1986
    Decision Date
    August 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 Intertech/Ohio

    K Number Device Name
    K895144 INTERTECH METERED DOSE ELBOW
    K890346 INTERTECH UNIVERSAL HYDROPHOBIC FILTER
    K884525 PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT
    K884526 ADULT RESUSCITATOR WITH MASK AND FILTER
    K882204 RESUSCITATOR VALVE ASSEMBLY W/FILTER
    K880394 FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR
    K862020 HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER
    K860650 90 DEGREE ELBOW & STRAIGHT CONNECTOR
    K861056 STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG