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

    SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer

    K Number: K170071 · Decision Nov 9, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    304

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    Basic Information

    Device Name
    SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer
    K Number
    K170071
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sleep Group Solutions
    Date Received
    January 9, 2017
    Decision Date
    November 9, 2017
    Product Code
    BXQ
    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
    BXQ Rhinoanemometer (Measurement Of Nasal Decongestion)

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