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510(k) Data Aggregation

    K Number
    K971492
    Device Name
    AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR
    Manufacturer
    BEI MEDICAL SYSTEMS CO., INC.
    Date Cleared
    1997-09-05

    (134 days)

    Product Code
    HIG
    Regulation Number
    884.1700
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEI MEDICAL SYSTEMS CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended to distend the uterus by filling the uterine cavity with CO2 gas to facilitate viewing with a hysteroscope.
    Device Description
    This device is intended to distend the uterus by filling the uterine cavity with gas to facilitate viewing with a hysteroscope.
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