Fetal Doppler, Model FD88— 510(k) K182710

Name: FDA 510(k) clearance K182710
Creator: U.S. Food and Drug Administration
Published: 2019-03-01

Substantially Equivalent

Shenzzhen Luckcome Technology Inc., Ltd.

FDA 510(k) clearance K182710 for Fetal Doppler, Model FD88, Substantially Equivalent on 2019-03-01. Applicant: Shenzzhen Luckcome Technology Inc., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzzhen Luckcome Technology Inc., Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2018-09-27
Decision date: 2019-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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