BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Braemar Telemetry Patch System BTPS-1000

    Reg #: 3008773647 · FEI: 3008773647 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CARDIONET, LLC
    Registration Number
    3008773647
    FEI Number
    3008773647
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5750 S. 40th St Suite 5
    City
    Phoenix
    State
    AZ
    ZIP
    85040
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153473

    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
    Detector And Alarm, Arrhythmia DSI

    Proprietary Names

    Braemar Telemetry Patch System BTPS-1000 BTP-1000M (Monitor) ECG Recorder BTPS-1000 Braemar Telemetry Patch System BTP-1000S (Sensor) MCOT

    Establishment Types

    Repack or Relabel Medical Device