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

    RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE

    K Number: K000406 · Decision Apr 17, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    70

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    Basic Information

    Device Name
    RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
    K Number
    K000406
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rhino Metrics A/S
    Date Received
    February 7, 2000
    Decision Date
    April 17, 2000
    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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