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510(k) Data Aggregation

    K Number
    K214073
    Device Name
    eWave Monitor
    Manufacturer
    WearLinq, Inc.
    Date Cleared
    2022-10-20

    (297 days)

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

    WearLinq, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The eWave monitor is an ambulatory ECG monitor intended to provide continuous extended duration cardiac monitoring. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, fatigue, or anxiety.
    Device Description
    Not Found
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