BEUDAMED
    FDA Registration Active 🇮🇳 India

    Sleepware G3, Event Detection Software

    Reg #: 3033526676 · FEI: 3033526676 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips India Limited - Sleep & Respiratory Care Business Unit
    Registration Number
    3033526676
    FEI Number
    3033526676
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka
    City
    Bengaluru Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K202142

    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

    US Agent

    Business Name
    Philips
    Contact Name
    Tom Fallon
    Address
    6501 Living Place
    City
    Pittsburgh
    State
    PA
    ZIP
    15206
    Country
    US
    Email
    [email protected]
    Phone
    978 9415572

    Products

    Device Name Product Code
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ

    Proprietary Names

    Sleepware G3, Event Detection Software

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)