ACT Cellular Phone Monitor

  • Modelo / Serial
    Models Ozone-HTC and BlackJack2 SGH-i617, all serial numbers with software version 5.5.9
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automatically activated system with a high performance EKG, office hookup and auto send/auto detect that requires no patient intervention to either capture or transmit an arrhythmia when it occurs; Manufactured by Card Guard, 2 Pekeris St, Rehovot, 76100, Israel; there are two models used with either the ACT 1 sensor or the ACT III sensor: || a) Model Ozone-HTC || b) Model BlackJack2 SGH-i617 || LifeStar ACT provides critical ECG information by capturing the onset and termination/escape of an arrhythmia to assist in correctly identifying and treating the patient. Patients are monitored for up to 30 days and all of the data is available at the request of the physician during the service period and for 7 days following the end of service.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Lifewatch Services Inc, 10255 W Higgins Rd, O'Hare International Center II, Rosemont IL 60018-5606
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA