BEUDAMED
    FDA Registration Active 🇺🇸 United States

    989803151641, 12-Lead Complete Lead Set (IEC), Standard Length

    Reg #: 3016618143 · FEI: 3016618143 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    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
    K080999

    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
    Electrocardiograph DPS

    Proprietary Names

    989803151641, 12-Lead Complete Lead Set (IEC), Standard Length 989803151761, 15/16/18-Lead Upgrade Kit (IEC), Standard Length 989803151731, 12-Lead Limb Lead Set (AAMI/IEC), Long 989803151651, 12-Lead Complete Lead Set (AAMI), Long 989803151661, 12-Lead Complete Lead Set (IEC), Long 989803164281, USB Patient Data Cable, Class B 989803151751, 15/16/18-Lead Upgrade Kit (AAMI), Standard Length 989803151631, 12-Lead Complete Lead Set (AAMI), Standard Length 989803151771, 15/16/18-Lead Upgrade Kit (AAMI), Long 989803151711, 12-Lead Limb Lead Set (AAMI/IEC), Standard Length 989803151781, 15/16/18-Lead Upgrade Kit (IEC), Long 989803151691, 12-Lead Chest Lead Set (AAMI/IEC), Long 989803151671, 12-Lead Chest Lead Set (AAMI/IEC), Standard Length

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility