Endofresh Digestive Endoscopy System
FDA 510(k) clearance K192704 · decided 2020-09-02
Clearance details
- K-number
- K192704
- Device name
- Endofresh Digestive Endoscopy System
- Applicant
- Huizhou Xzing Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-27
- Decision date
- 2020-09-02
- Days to decision
- 341 days
- Clearance type
- Traditional
- Product code
- FDS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Huizhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.