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

    COSMO PLUS WITH NICO, MODEL 8200

    K Number: K982499 · Decision Oct 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    89
    Applicant Total
    45
    Review Days
    88

    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
    COSMO PLUS WITH NICO, MODEL 8200
    K Number
    K982499
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Novametrix Medical Systems, Inc.
    Date Received
    July 20, 1998
    Decision Date
    October 16, 1998
    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 Novametrix Medical Systems, Inc.

    K Number Device Name
    K010451 NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
    K000794 MODIFICATION TO MARSPO2, MODEL 2001
    K993979 MARSPO2, MODEL 2001
    K964360 VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
    K963380 CO 2 SMO PLUS
    K963327 TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
    K960831 VENTRAK RMMS 1550
    K924626 NOVAMETRIX MODEL 510
    K920379 NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
    K913516 MODEL 520A NOVAMETRIX PULSE OXIMETER
    Search all 45 clearances from Novametrix Medical Systems, Inc. →