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

    Etiometry Platform

    K Number: K254066 · Decision Apr 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    11
    Review Days
    106

    Basic Information

    Device Name
    Etiometry Platform
    K Number
    K254066
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Etiometry, Inc.
    Date Received
    December 18, 2025
    Decision Date
    April 3, 2026
    Product Code
    PPW
    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
    PPW Adjunctive Cardiovascular Status Indicator

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    Other Clearances by Etiometry, Inc.

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