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

    TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER

    K Number: K112529 · Decision Oct 27, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    59
    Applicant Total
    16
    Review Days
    57

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    Basic Information

    Device Name
    TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER
    K Number
    K112529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Instrumentations, Inc.
    Date Received
    August 31, 2011
    Decision Date
    October 27, 2011
    Product Code
    KNG
    Advisory Committee
    Obstetrics/Gynecology
    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
    KNG Monitor, Ultrasonic, Fetal

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    Other Clearances by Advanced Instrumentations, Inc.

    K Number Device Name
    K172931 DUS-6000 Digital Ultrasonic Diagnostic Imaging System
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    K132077 PATIENT MONITOR
    K132059 DIAGNOSTIC ULTRASOUND SYSTEM
    K123048 PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO
    K120075 AM-6000 ANESTHESIA MACHINE
    K112317 FM-9000 PLUS FETAL AND MATERNAL MONITOR
    K111934 PD-100 SERIES ULTRASONIC POCKET DOPPLER
    K112022 DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
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