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

    TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM

    K Number: K946277 · Decision Mar 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    5
    Review Days
    444

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    Basic Information

    Device Name
    TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM
    K Number
    K946277
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tetra Corp.
    Date Received
    December 27, 1994
    Decision Date
    March 15, 1996
    Product Code
    IYN
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Tetra Corp.

    K Number Device Name
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    K945318 TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA
    K945319 TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT
    K924204 NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS