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

    MODEL 65 HIGH & LOW PRESSURE ALARM

    K Number: K780863 · Decision Aug 21, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    77
    Applicant Total
    20
    Review Days
    83

    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
    MODEL 65 HIGH & LOW PRESSURE ALARM
    K Number
    K780863
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2600
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    The John Bunn Co.
    Date Received
    May 30, 1978
    Decision Date
    August 21, 1978
    Product Code
    CAP
    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
    CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

    Similar 510(k) Clearances

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

    SINGLE USE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VORTRAN APM-Plus

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NS 120P-TRS Airway Pressure Gauge

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NAPA LP-15 Airway Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VORTRAN Manometer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Disposable Pressure Manometer (DPM)

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

    Other Clearances by The John Bunn Co.

    K Number Device Name
    K900854 JOHN BUNN: MEDIX COMPACT TRAVELLER
    K883216 BUNN MODEL 50 OXYGEN FLOW CONTROLLER
    K873071 BUNN CONCENTRATOR MODEL 2100 SERIES
    K870094 BUNN MODEL 530 ASPIRATOR
    K861435 BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE
    K861199 BUNN MODEL 22 OXYGEN FLOW CONTROLLER
    K862628 BUNN MODEL 510 MEDICATION COMPRESSOR
    K855208 BUNN LITE OXYGEN CONCENTRATOR
    K860060 RX02 PLUS OXYGEN CONCENTRATOR
    K843811 BUNN 3001 OXYGEN CONCENTRATOR
    Search all 20 clearances from The John Bunn Co. →