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

    SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901

    K Number: K092611 · Decision Apr 28, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    245

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    Basic Information

    Device Name
    SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901
    K Number
    K092611
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sonarmed, Inc.
    Date Received
    August 26, 2009
    Decision Date
    April 28, 2010
    Product Code
    OQU
    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
    OQU Airway Monitoring System

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    Other Clearances by Sonarmed, Inc.

    K Number Device Name
    K193058 SonarMed AirWave Airway Monitoring System
    K143042 SonarMed AirWave, Airway Monitoring System