BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇴 Norway

    MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004

    K Number: K992305 · Decision Sep 8, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    2
    Review Days
    62

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    Basic Information

    Device Name
    MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
    K Number
    K992305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medi-Stim A/S
    Date Received
    July 8, 1999
    Decision Date
    September 8, 1999
    Product Code
    ITX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITX Transducer, Ultrasonic, Diagnostic

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