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510(k) Data Aggregation

    K Number
    K013804
    Device Name
    SOCRATES ROBOTIC TELEMONITORING SYSTEM
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2001-12-10

    (25 days)

    Product Code
    NEQ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    NEQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOCRATES System is indicated for use in general cardiothoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy, and sinuscopy where a general laparoscope/endoscope is indicated for use. A few example indications are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. Use of the SOCRATES System enables a remote surgeon to telecommunicate with any AESOP™ Robotic System and assist the local surgeon with field-of-view positioning.
    Device Description
    Not Found
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    K Number
    K003661
    Device Name
    SOCRATES ROBOTIC TELEMONITORING SYSTEM
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2001-10-05

    (311 days)

    Product Code
    NEQ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    NEQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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