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

    SIMEOX 200 Airway Clearance Device

    K Number: K241091 · Decision Dec 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    245

    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
    SIMEOX 200 Airway Clearance Device
    K Number
    K241091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5665
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inogen, Inc.
    Date Received
    April 22, 2024
    Decision Date
    December 23, 2024
    Product Code
    SDT
    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
    SDT Intra-Pulmonary Percussive Vibration (Ipv) Devices

    Similar 510(k) Clearances

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

    VIBRALUNG ACOUSTICAL PERCUSSOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RESPIRONICS SIMPLYCLEAR DEVICE

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

    Other Clearances by Inogen, Inc.

    K Number Device Name
    K230052 Inogen Rove 6
    K132489 INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)
    K032818 INOGEN ONE OXYGEN CONCENTRATOR