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510(k) Data Aggregation

    K Number
    K112601
    Device Name
    INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
    Manufacturer
    INTRICON DATRIX CORPORATION
    Date Cleared
    2011-11-09

    (63 days)

    Product Code
    MWJ
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRICON DATRIX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntriCon Sirona is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. When event data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician. The IntriCon Datrix Sirona is a combination Event Recorder and Holter Recorder that is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. In the Event Recorder mode, once event data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician. In the Holter Recorder mode, the device is intended for the recording of ECG data collected from ambulatory patients. The data is then reviewed by the physician after downloading and processing by a Holter playback system.
    Device Description
    The IntriCon Sirona is a device for use as either an Event Recorder (ER), with or without Arrhythmia Detection, or Holter Monitor (HM). The device can operate in one of three modes depending on clinician selected options.
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    K Number
    K111160
    Device Name
    INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
    Manufacturer
    INTRICON DATRIX CORPORATION
    Date Cleared
    2011-08-01

    (98 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRICON DATRIX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntriCon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (APETS) is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an event triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.
    Device Description
    The IntriCon Datrix Centauri MT APETS is a device used for recording patient ECG data for as long as 30 days. Selected data are sent for review from the recorder, through a phone service to a receiving station where they are available for review by a physician or other qualified medical professional. The Centauri MT APETS is capable of 1, 2, and 3-channel recording, depending on the type of cable being used. The recorder can run for up to 30 days. Battery life depends on the mode and battery option chosen by the user. The patient's ECG signal is acquired via commercially available silver-chloride electrodes appropriate for long-term recording.
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