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Esophageal, Mucosal, Electrical Characterization

FDA product code QIS · 2 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.1450
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-04-25 – 2024-09-06

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

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