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

    LCI OPTION FOR INNOCOR

    K Number: K102047 · Decision Nov 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    89
    Applicant Total
    4
    Review Days
    468

    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
    LCI OPTION FOR INNOCOR
    K Number
    K102047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovision A/S
    Date Received
    July 21, 2010
    Decision Date
    November 1, 2011
    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

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

    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
    View all

    Other Clearances by Innovision A/S

    K Number Device Name
    K083879 INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)
    K071911 CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR
    K051907 INNOCOR