BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    989803184831 FR3 Software Version PR2.1 Upgrade

    Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips Electronics Ltd
    Registration Number
    3000126629
    FEI Number
    3000126629
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1875 Buckhorn Gate, 5th Floor
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    PMA Number
    P160028

    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
    Shaylee Masilunas
    Address
    6501 Living Place
    City
    Pittsburgh
    State
    PA
    ZIP
    15206
    Country
    US
    Email
    [email protected]
    Phone
    724 8162019

    Products

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

    Proprietary Names

    989803184831 FR3 Software Version PR2.1 Upgrade 989803150171 Aviation Battery FR3 989803150161 Primary Battery 989803149981 and 989803149991 SMART Pads III 989803150031 Pediatric Key 989803149971 FR3 Rigid System Case with bottom insert and Pads Sentry 989803158211 and 989803158221 DP Pads 989803150041 FR3 3-Lead ECG Cable (AAMI) with Storage Pouch 861389 HeartStart FR3 Defibrillator (ECG Display) 989803150241 Rechargeable Battery 989803149951 - Cable Link, FR3 to Q-CPR Meter 861394 Charger for the Rechargeable Battery 861388 HeartStart FR3 Defibrillator (Text) 989803150051 FR3 3-Lead ECG Cable (IEC) with Storage Pouch

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device