CONTEC POCKET FETAL DOPPLER— 510(k) K082480

Name: FDA 510(k) clearance K082480
Creator: U.S. Food and Drug Administration
Published: 2009-02-25

Substantially Equivalent

Contec Medical System Co., Ltd.

FDA 510(k) clearance K082480 for CONTEC POCKET FETAL DOPPLER, Substantially Equivalent on 2009-02-25. Applicant: Contec Medical System Co., Ltd.. Device class: 2.

Clearance details

Applicant: Contec Medical System Co., Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2008-08-28
Decision date: 2009-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhong Shan, Shanghai, CN

Download summary PDF View on FDA.gov ↗

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