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

    SonarMed AirWave Airway Monitoring System

    K Number: K193058 · Decision May 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    196

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    Basic Information

    Device Name
    SonarMed AirWave Airway Monitoring System
    K Number
    K193058
    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
    November 1, 2019
    Decision Date
    May 15, 2020
    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

    Similar 510(k) Clearances

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

    SonarMed AirWave, Airway Monitoring System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901

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

    Other Clearances by Sonarmed, Inc.

    K Number Device Name
    K143042 SonarMed AirWave, Airway Monitoring System
    K092611 SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901