Incontinence Treatment Device, Model LT2061— 510(k) K171430

Substantially Equivalent

Shenzhen Dongdixin Technology Co., Ltd.

FDA 510(k) clearance K171430 for Incontinence Treatment Device, Model LT2061, Substantially Equivalent on 2018-03-15. Applicant: Shenzhen Dongdixin Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant
Shenzhen Dongdixin Technology Co., Ltd.
Product code
Code KPI
Device class
Class 2
Regulation
21 CFR 876.5320
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shenzhen, CN
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