BEUDAMED
    FDA Registration Active 🇫🇷 France

    Ulspira TS Nitric Oxide Therapy System

    Reg #: 3019771924 · FEI: 3019771924 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    INOSYSTEMS
    Registration Number
    3019771924
    FEI Number
    3019771924
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7 RUE GEORGES BESSE
    City
    ANTONY Hauts-de-Seine
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K242374

    Owner / Operator

    Firm Name
    INOSYSTEMS
    Operator Number
    10088379
    Address
    7 RUE GEORGES BESSE
    City
    ANTONY
    State
    Hauts-de-Seine
    Postal Code
    92160
    Country
    FR
    Correspondent
    SOPHIE DUBOUDIN

    US Agent

    Business Name
    K&L Gates LLP
    Contact Name
    Michael H.Hinckle
    Address
    430 Davis Drive, Suite 400, Research Triangle Park Office
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US
    Email
    [email protected]
    Phone
    919 4661115

    Products

    Device Name Product Code
    Analyzer, Nitric Oxide MRP
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Nitrogen Dioxide MRQ
    Apparatus, Nitric Oxide, Backup Delivery MRO
    Apparatus, Nitric Oxide Delivery MRN

    Proprietary Names

    Ulspira TS Nitric Oxide Therapy System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)