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

    AccurECG Analysis System (v2.0)

    K Number: K252361 · Decision Dec 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    2
    Review Days
    146

    Basic Information

    Device Name
    AccurECG Analysis System (v2.0)
    K Number
    K252361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accurkardia, Inc.
    Date Received
    July 29, 2025
    Decision Date
    December 22, 2025
    Product Code
    DPS
    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
    DPS Electrocardiograph

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    Other Clearances by Accurkardia, Inc.

    K Number Device Name
    K223013 AccurECG Analysis System