BEUDAMED
    FDA Registration Active 🇺🇸 United States

    989803183101 989803183101

    Reg #: 3016618143 · FEI: 3016618143 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips North America LLC
    Registration Number
    3016618143
    FEI Number
    3016618143
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02141
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011564

    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
    Electrode, Electrocardiograph DRX

    Proprietary Names

    989803183101 989803183101 989803183121 NeoLead, AAMI radio lead 989803183081 Mini NeoLead, AAMI metal lead 989803183141 Micro NeoLead, AAMI radio lead

    Establishment Types

    Repack or Relabel Medical Device