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510(k) Data Aggregation
K Number
K010754Device 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
876.1500Why 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
K010716Device 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
878.4580Why 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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