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510(k) Data Aggregation

    K Number
    K010754
    Device Name
    NURSE'S ASSISTANT O.R. CONTROL SYSTEM
    Manufacturer
    VAL MED CORP.
    Date Cleared
    2001-08-15

    (155 days)

    Product Code
    GCJ, FET, FSY, HET
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VAL MED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Val Med Nurse's Assistant is intended to be used to turn on and off and adjust certain settings of endoscopic and surgical cameras, surgical lamps, and operating room ("O.R.") lights, and to operate VCRs, monitors, video printers, radios, and CD players. The Val Med Nurse's Assistant is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thorascoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy. A few examples of the more common surgical procedures where this system could be used are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anteriorspinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated, examination of the evacuated cardiac chamber during performance of valve replacement, arthroscopic meniscus repair, anterior cruciate ligament repair and associated procedures.
    Device Description
    The Val Med's Nurse's Assistant is a computer with a monitor and touch screen that a nurse uses in the operating room to activate and control the following equipment: (1) surgical cameras, including an endoscopic camera; (2) room or surgeons' nurses' lounge cameras ("operating room cameras"); (3) surgical lights; (4) room lights; (5) a VCR; (6) a video printer; (7) video monitor(s); (8) a radio; and (9) a CD player. Val Med's Nurse's Assistant controls one or more electrical dimmer switches, which in turn control the surgical lights.
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    K Number
    K010716
    Device Name
    VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB
    Manufacturer
    VAL MED CORP.
    Date Cleared
    2001-05-30

    (82 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    VAL MED CORP.

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