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

    ACOUSTIC RHINOMETER

    K Number: K921452 · Decision Jul 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    19
    Review Days
    469

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    Basic Information

    Device Name
    ACOUSTIC RHINOMETER
    K Number
    K921452
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hood Laboratories
    Date Received
    March 26, 1992
    Decision Date
    July 8, 1993
    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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    K897059 HOOD SPEAKING VALVE
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