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

    Analytic for Hemodynamic Instability (AHI)

    K Number: DEN200022 · Decision Mar 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    332

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Analytic for Hemodynamic Instability (AHI)
    K Number
    DEN200022
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.2220
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Fifth Eye, Inc.
    Date Received
    April 3, 2020
    Decision Date
    March 1, 2021
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QNV), ordered by most recent decision date.

    AHI System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AHI System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Fifth Eye, Inc.

    K Number Device Name
    K221203 AHI System
    K212219 AHI System