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510(k) Data Aggregation

    K Number
    K122356
    Device Name
    ALIVECOR HEART MONITOR FOR IPHONE
    Manufacturer
    ALIVECOR, INC.
    Date Cleared
    2012-11-19

    (108 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AliveCor Heart Monitor for iPhone is intended for use by licensed medical professionals or patients to record, display, store and transfer single-channel electrocardiogram (ECG) rhythms.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA for the AliveCor Heart Monitor for iPhone. It acknowledges the receipt and review of the device and states that it is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or a study proving the device meets acceptance criteria. It is a notification of substantial equivalence, not a detailed report of clinical trials or performance metrics.

    Therefore, I cannot provide the requested information based on the provided text.

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