BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    AITRICS-VC

    K Number: K240756 · Decision Jul 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    125

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    Basic Information

    Device Name
    AITRICS-VC
    K Number
    K240756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aitrics Co., Ltd.
    Date Received
    March 20, 2024
    Decision Date
    July 23, 2024
    Product Code
    PLB
    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
    PLB Multivariate Vital Signs Index

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