BEUDAMED
    FDA Registration Active 🇺🇸 United States

    989803156241 Adult Disposable Metallic 5 Leadwire Electrode Set, AAMI

    Reg #: 3016618143 · FEI: 3016618143 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    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
    K080106

    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

    989803156241 Adult Disposable Metallic 5 Leadwire Electrode Set, AAMI 989803156201 Adult Disposable Metallic 3 Leadwire Electrode Set, AAMI 989803156221 Adult Disposable Radiolucent 3 Leadwire Electrode Set, AAMI 989803156231 Adult Disposable Radiolucent 3 Leadwire Electrode Set, IEC 989803156261 Adult Disposable Radiolucent 5 Leadwire Electrode Set, AAMI 989803156271 Adult Disp Radiolucent 5 Leadwire Electrode Set, IEC

    Establishment Types

    Repack or Relabel Medical Device