FETAL DOPPLER— 510(k) K112911

Name: FDA 510(k) clearance K112911
Creator: U.S. Food and Drug Administration
Published: 2011-10-27

Substantially Equivalent

Beijing Choice Electronic Technololgy Co., Ltd.

FDA 510(k) clearance K112911 for FETAL DOPPLER, Substantially Equivalent on 2011-10-27. Applicant: Beijing Choice Electronic Technololgy Co., Ltd.. Device class: 2.

Clearance details

Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2011-10-03
Decision date: 2011-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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