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U.S. Department of Health and Human Services

Product Classification
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Device endoscopic central control unit
Regulation Description Endoscope and accessories.
Definition To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.
Physical State may include: monitor, remote (or other wireless device), microphone, card adaptor, cables, other hardware and software
Technical Method Connect operating systems into central control unit
Target Area endoscopic and other ancillary surgical equipment
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeODA
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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