BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    NIOX MINO MODEL 09-1000

    K Number: K101034 · Decision Sep 2, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    6
    Review Days
    141

    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
    NIOX MINO MODEL 09-1000
    K Number
    K101034
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3080
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aerocrine AB
    Date Received
    April 14, 2010
    Decision Date
    September 2, 2010
    Product Code
    MXA
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MXA System, Test, Breath Nitric Oxide

    Similar 510(k) Clearances

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

    Fenom Flo™ FeNO Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Vivatmo pro-S

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Vivatmo pro

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Fenom Pro

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NObreath®

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Fenom Pro Nitric Oxide Test

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    Other Clearances by Aerocrine AB

    K Number Device Name
    K150233 NIOX VERO Airway Inflammation Monitor
    K133898 NIOX VERO AIRWAY INFLAMMATION MONITOR
    K123683 NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
    K072816 NIOX MINO
    DEN030001 NIOX ARTICLE NO: 02-1000