BEUDAMED
    FDA Registration Active 🇺🇸 United States

    05-10100 - Heartstream Pads to Zoll Adapter

    Reg #: 3012607778 · FEI: 3012607778 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    3012607778
    FEI Number
    3012607778
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15100 Woodinville-Redmond Road NE, Bldg A, Suite 300
    City
    Woodinville
    State
    WA
    ZIP
    98072
    Country
    US

    Regulatory Submissions

    510(k) Number
    K984286

    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

    Products

    Device Name Product Code
    Automated External Defibrillators (Non-Wearable) MKJ

    Proprietary Names

    05-10100 - Heartstream Pads to Zoll Adapter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility