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

    prolaio eVO2peak Module (Version 1.0)

    K Number: K252204 · Decision Dec 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    155

    Basic Information

    Device Name
    prolaio eVO2peak Module (Version 1.0)
    K Number
    K252204
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prolaio, Inc.
    Date Received
    July 14, 2025
    Decision Date
    December 16, 2025
    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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