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

    OXY-ON DIGITAL OXYGEN TIMER

    K Number: K781039 · Decision Aug 31, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    73

    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
    OXY-ON DIGITAL OXYGEN TIMER
    K Number
    K781039
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2885
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Chambers & Sadler Mfg.
    Date Received
    June 19, 1978
    Decision Date
    August 31, 1978
    Product Code
    BXP
    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
    BXP Transducer, Gas Flow

    Similar 510(k) Clearances

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

    UNIPOWER RECHARGEABLE BATTERY PACK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    TIMOX OXYGEN TIMER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PHONATORY FUNCTION ANALYZER PS-77

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ULTRASONIC FLOWMETER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    OXYGEN TWMER, MODEL SST

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ARIZONA OXYGEN TIMER DEVICE

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