MODEL PC-860 FETAL DOPPLER— 510(k) K082055

Name: FDA 510(k) clearance K082055
Creator: U.S. Food and Drug Administration
Published: 2009-02-06

Substantially Equivalent

Shenzhen Creative Industry Co., Ltd.

FDA 510(k) clearance K082055 for MODEL PC-860 FETAL DOPPLER, Substantially Equivalent on 2009-02-06. Applicant: Shenzhen Creative Industry Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Creative Industry Co., Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2008-07-21
Decision date: 2009-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chenzhen City, 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.