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

    AHI System

    K Number: K221203 · Decision Jul 14, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    79

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    Basic Information

    Device Name
    AHI System
    K Number
    K221203
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fifth Eye, Inc.
    Date Received
    April 26, 2022
    Decision Date
    July 14, 2022
    Product Code
    QNV
    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
    QNV Adjunctive Hemodynamic Indicator With Decision Point

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    Other Clearances by Fifth Eye, Inc.

    K Number Device Name
    K212219 AHI System
    DEN200022 Analytic for Hemodynamic Instability (AHI)