Fetal Doppler— 510(k) K212084

Name: FDA 510(k) clearance K212084
Creator: U.S. Food and Drug Administration
Published: 2021-11-03

Substantially Equivalent

Shenzhen Mericonn Technology Co., Ltd.

FDA 510(k) clearance K212084 for Fetal Doppler, Substantially Equivalent on 2021-11-03. Applicant: Shenzhen Mericonn Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Mericonn Technology Co., Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2021-07-02
Decision date: 2021-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)2022-09-28

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