BEUDAMED
    FDA Registration Active 🇫🇷 France

    SIMEOX 200 Airway Clearance Device

    Reg #: 3019585099 · FEI: 3019585099 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PHYSIO-ASSIST
    Registration Number
    3019585099
    FEI Number
    3019585099
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    31 parc du Golf CS 90519
    City
    Aix-en-Provence Provence-Alpes-Cote d'Azur
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K241091

    Owner / Operator

    Firm Name
    Inogen
    Operator Number
    10092925
    Address
    31 Parc du Golf CS90519
    City
    Aix-en-Provence
    State
    Provence-Alpes-Cote d'Azur
    Postal Code
    13593
    Country
    FR
    Correspondent
    Agnes NDOUR

    US Agent

    Business Name
    INOGEN, INC
    Contact Name
    Kevin Ford
    Address
    859 Ward Dr
    City
    Goleta
    State
    CA
    ZIP
    93111
    Country
    US
    Email
    [email protected]
    Phone
    901 6341611

    Products

    Device Name Product Code
    Intra-Pulmonary Percussive Vibration (Ipv) Devices SDT

    Proprietary Names

    SIMEOX 200 Airway Clearance Device

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device