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

    B&B BUBBLER

    K Number: K133210 · Decision Mar 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    72
    Same Product Code
    79
    Applicant Total
    1
    Review Days
    162

    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
    B&B BUBBLER
    K Number
    K133210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5965
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    S & T Medical Technologies, Inc.
    Date Received
    October 17, 2013
    Decision Date
    March 28, 2014
    Product Code
    BYE
    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
    BYE Attachment, Breathing, Positive End Expiratory Pressure

    Similar 510(k) Clearances

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

    Besmed PEEP Valve

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    O_TWO CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WATERPAP VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NEOPIP PATIENT CIRCUIT WITH PEEP

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