BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SignalHF (IM008)

    K Number: K230842 · Decision Oct 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    211

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    Basic Information

    Device Name
    SignalHF (IM008)
    K Number
    K230842
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Implicity, Inc.
    Date Received
    March 28, 2023
    Decision Date
    October 25, 2023
    Product Code
    QNL
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QNL Medium-Term Adjunctive Predictive Cardiovascular Indicator

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    Other Clearances by Implicity, Inc.

    K Number Device Name
    K210543 IM007