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

    Somnera System

    K Number: K200698 · Decision Jun 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    104

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    Basic Information

    Device Name
    Somnera System
    K Number
    K200698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5273
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresca Medical, Inc.
    Date Received
    March 17, 2020
    Decision Date
    June 29, 2020
    Product Code
    QBY
    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
    QBY Positive Airway Pressure System

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