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510(k) Data Aggregation

    K Number
    K022311
    Device Name
    RHINOSTREAM RHINOMANOMETER MODULE
    Manufacturer
    RHINOMETRICS A/S
    Date Cleared
    2002-10-04

    (79 days)

    Product Code
    BXQ
    Regulation Number
    868.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RHINOMETRICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Rhinomanometer is a medical instrument, intended to measure nasal airway pressure up to 5 centimeters H2O. (500Pa) and air flow up to 1000 ml/s. (2001 a) and in the now ap to roove. which is useful to the physician in studying the nasal decongestion of the nasal This is a not it as re procedures, before and after surgical procedures, responses to medications, presence or absence of polyps, deviated septums, enlarged adenoids, etc.
    Device Description
    The RhinoStream Rhinomanometer module is designed to objectively and quickly measure and quantify a dynamic measure of the patient ability breath through the nasal airway passages.
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    K Number
    K000406
    Device Name
    RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE
    Manufacturer
    RHINOMETRICS A/S
    Date Cleared
    2000-04-17

    (70 days)

    Product Code
    BXQ
    Regulation Number
    868.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    RHINOMETRICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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