BEUDAMED
    FDA Registration Active 🇨🇳 China

    WhisperFlow Procedure Packs

    Reg #: 3003001596 · FEI: 3003001596 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RESPIRONICS MEDICAL PRODUCTS (SHENZHEN) CO., LTD.
    Registration Number
    3003001596
    FEI Number
    3003001596
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Block 6 & 7, No. 129, 2nd Industrial Avenue, Tang Xia Yong Village, Yan Luo Sub-district, Bao An District
    City
    SHENZHEN Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K982283

    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
    Attachment, Breathing, Positive End Expiratory Pressure BYE

    Proprietary Names

    WhisperFlow Procedure Packs

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)