BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Panther 5N

    Reg #: 3010088563 · FEI: 3010088563 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORIGIN MEDICAL DEVICES INC
    Registration Number
    3010088563
    FEI Number
    3010088563
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    23 Corporate Plaza, Suite 150
    City
    Newport Beach
    State
    CA
    ZIP
    92660
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213098

    Owner / Operator

    Firm Name
    Origin Medical Devices Inc
    Operator Number
    10081924
    Address
    23 Corporate Plaza, Suite 150
    City
    Newport Beach
    State
    CA
    Postal Code
    92660
    Country
    US
    Correspondent
    Ory Gur

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    Panther 5N Panther 5 Panther 3V Panther 3

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility