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U.S. Department of Health and Human Services

Product Classification
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Device esophageal, mucosal, electrical characterization
Regulation Description Esophageal tissue characterization system.
Definition The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
Physical State The device consists of a probe, cables, and other processing equipment to record and display the electrical characteristics of the esophageal tissue.
Technical Method The device goes into the esophagus and comes in contact with the tissue. Through sensors or other means, the electrical characterization of the tissue is recorded and later displayed.
Target Area Esophagus
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeQIS
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 876.1450
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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