CAD - Lower GI (EC07-01)— 510(k) K252853
Substantially EquivalentXiamen 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
Recent devices under product code QNP
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