Cleared Traditional

Fetal Doppler

K211940 · Shenzhen Taikang Medical Equipment Co., Ltd. · Obstetrics & Gynecology

Jan 2022

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K211940 is an FDA 510(k) clearance for the Fetal Doppler, a Monitor, Ultrasonic, Fetal (Class II — Special Controls, product code KNG), submitted by Shenzhen Taikang Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 7, 2022, 198 days after receiving the submission on June 23, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number	K211940 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2021
Decision Date	January 07, 2022
Days to Decision	198 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF