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

    SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES

    K Number: K904017 · Decision Mar 21, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    8
    Review Days
    203

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    Basic Information

    Device Name
    SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES
    K Number
    K904017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Siemens Ultrasound, Inc.
    Date Received
    August 30, 1990
    Decision Date
    March 21, 1991
    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 Siemens Ultrasound, Inc.

    K Number Device Name
    K912361 SI-450/ILUS (INTRALUMINAL ULTRASOUND)
    K914013 SIEMENS SI-400
    K911200 SI-1200 / ILUS
    K910529 7.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANS
    K910669 5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU
    K891449 SONOLINE CF
    K891238 SIEMENS TRANSESOPHAGEAL ECHO TEE TRANSDUCER