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FDA product code QIS

Esophageal, Mucosal, Electrical Characterization

Gastroenterology, UrologyClass 221 CFR 876.1450
Verified
US regulatory classifications
US Product Code (FDA)
QIS
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.1450
View CFR Regulation
Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.

Search keywords

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01Esophageal impedance02GI impedance03Mucosal impedance04Reflux test05Esophageal monitoring06Motility test07pH monitoring08GI diagnostic09Esophagus sensor10Electrical measurement
About this record

Esophageal, Mucosal, Electrical Characterization is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.