BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART

    K Number: K181524 · Decision Nov 30, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    89
    Applicant Total
    9
    Review Days
    172

    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
    Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
    K Number
    K181524
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vyaire Medical, Inc.
    Date Received
    June 11, 2018
    Decision Date
    November 30, 2018
    Product Code
    BZC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BZC Calculator, Pulmonary Function Data

    Similar 510(k) Clearances

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

    STS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vyntus/SentrySuite Product Line

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vyntus BODY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    COSMED K5 Wearable Metabolic Technology

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MiniBox +

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vyntus / SentrySuite Product Line

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

    Other Clearances by Vyaire Medical, Inc.

    K Number Device Name
    K230915 AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask
    K231380 AirLife DuoTherm™ Humidification System
    K201082 LTV2 Series Ventilators
    K211294 Multi-Link X2 ECG Cable and Leadwire System
    K200510 Multi-LinkTM X2 ECG Adapter and Leadwires
    K191273 Multi-Link X2 ECG and SpO2 Adapter
    K190853 Vyntus BODY
    K171678 Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable