BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ePatch ECG Recorder

    Reg #: 3016812424 · FEI: 3016812424 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CARDIONET, LLC
    Registration Number
    3016812424
    FEI Number
    3016812424
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600 West Ridge Road
    City
    Linwood
    State
    PA
    ZIP
    19061
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171410

    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
    Recorder, Magnetic Tape, Medical DSH

    Proprietary Names

    ePatch ECG Recorder ECG Recorder ePatch

    Establishment Types

    Repack or Relabel Medical Device