BEUDAMED
    FDA Registration Active 🇺🇸 United States

    989803184831 FR3 Software Version PR2.1 Upgrade

    Reg #: 3030677 · FEI: 1000524572 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    3030677
    FEI Number
    1000524572
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    22100 Bothell Everett Hwy
    City
    Bothell
    State
    WA
    ZIP
    98021
    Country
    US

    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

    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

    Manufacture Medical Device