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510(k) Data Aggregation

    K Number
    K182532
    Device Name
    Liba3 System
    Manufacturer
    National Cardiac, Inc.
    Date Cleared
    2019-05-15

    (243 days)

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

    National Cardiac, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Liba3 ™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified healthcare professional for out-patient individuals with known non-lethal arrhythmias such as: - · Atrial Fibrillation - · Bradycardia - · Tachycardia · Pause It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the Liba3™ will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and transmitted ECG data are available to HealthCare Providers for analysis and reporting. Liba3™ is intended to be used with adult patients 22 years and older, but not designed for pediative patients.
    Device Description
    The Liba3™ System is a wearable, wireless arrhythmia detection system that provides continuous cardiac monitoring functionality for an extended period of time. Each Sensor can be worn for up to 7.5 days. If the prescribed monitoring period exceeds 7.5 days. National Cardiac. Inc. will provide additional sensors. For a 30-day monitoring period, the patient would be required to use four (4) Sensor components. The Liba3 System is prescribed by healthcare providers to monitor, record, and report on a patient's electrocardiographic (ECG) data. The Liba3 system consists of: (1) a wearable electronic component that collects and monitors a patient's single lead ECG data referred to as a Liba3TM Sensor; (2) an optional transmitting device, referred to as the Liba3 transmitting device, that is used for ECG data transmission while the patient is wearing the sensor and for transmission of patient triggered events; and (3) a Remote Data Management System (RDMS) which is a remote server with software that will allow qualified healthcare providers to receive, analyze, interpret, and report on the results of the ECG test.
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