Fetal Doppler— 510(k) K211940

Name: FDA 510(k) clearance K211940
Creator: U.S. Food and Drug Administration
Published: 2022-01-07

Substantially Equivalent

Shenzhen Taikang Medical Equipment Co., Ltd.

FDA 510(k) clearance K211940 for Fetal Doppler, Substantially Equivalent on 2022-01-07. Applicant: Shenzhen Taikang Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Taikang Medical Equipment Co., Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2021-06-23
Decision date: 2022-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNG

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K252669 — Fetal Doppler U8-25, U9-252026-01-08
K242846 — Doppler FHR Detector (BF-500D+, BF-560)2025-06-26
K233823 — Ultrasonic Fetal Doppler2024-06-28
K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)2024-06-14
K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)2022-09-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.