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

    T3 Platform software

    K Number: K213423 · Decision Jan 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    11
    Review Days
    443

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    Basic Information

    Device Name
    T3 Platform software
    K Number
    K213423
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Etiometry, Inc.
    Date Received
    October 20, 2021
    Decision Date
    January 6, 2023
    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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    Other Clearances by Etiometry, Inc.

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    K190273 T3 Platform software
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