BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    A1 ACOUSTIC RHINOMETER

    K Number: K972140 · Decision Sep 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    481

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    Basic Information

    Device Name
    A1 ACOUSTIC RHINOMETER
    K Number
    K972140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    G.M. Instruments , Ltd.
    Date Received
    June 6, 1997
    Decision Date
    September 30, 1998
    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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