BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PC Direct

    Reg #: 3007220521 · FEI: 3007220521 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RESPIRONICS, INC.
    Registration Number
    3007220521
    FEI Number
    3007220521
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    312 Alvin Drive
    City
    New Kensington
    State
    PA
    ZIP
    15068
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090539

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    2518422
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Ventilator, Continuous, Non-Life-Supporting MNS

    Proprietary Names

    PC Direct Omnilab Direct BiPAP autoSV Advanced System One BiPAP w/ & w/o Humidifier Omnilab Advanced/Advanced + DreamStation BiPAP AVAPS w/ & w/o Humidifier DreamStation BiPAP autoSV w/ & w/o Humidifier DreamStation BiPAP S/T w/ & w/o Humidifier

    Establishment Types

    Manufacture Medical Device