EndoScreener— 510(k) K211326

Substantially Equivalent

Chengdu Wision Medical Device Co., Ltd.

FDA 510(k) clearance K211326 for EndoScreener, Substantially Equivalent on 2021-11-19. Applicant: Chengdu Wision Medical Device Co., Ltd.. Device class: 2.

Clearance details

Applicant
Chengdu Wision Medical Device 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
Chengdu, CN
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