BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PageWriter TC35 Cardiograph, TC35 (860437)

    Reg #: 9610816 · FEI: 3002807167 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips Medizin Systeme Boeblingen GmbH
    Registration Number
    9610816
    FEI Number
    3002807167
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HEWLETT-PACKARD STRASSE 2
    City
    BOEBLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K221141

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Deborah Currlin
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02141
    Country
    US
    Email
    [email protected]
    Phone
    858 9452753

    Products

    Device Name Product Code
    Electrocardiograph DPS

    Proprietary Names

    PageWriter TC35 Cardiograph, TC35 (860437) 12-Lead Patient Cables: 989803184921, 989803184931, 989803184941, 989803184951

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility