CAD - Lower GI (EC07-01)— 510(k) K252853

Substantially Equivalent

Xiamen Inno Medical Technology Co., Ltd.

FDA 510(k) clearance K252853 for CAD - Lower GI (EC07-01), Substantially Equivalent on 2026-08-05. Applicant: Xiamen Inno Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant
Xiamen Inno Medical Technology Co., Ltd.
Product code
Code QNP
Device class
Class 2
Regulation
21 CFR 876.1520
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Xiamen, CN
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