TRANSTEK GLASS BODY ANALYZER (4 models)— 510(k) K102191

Name: FDA 510(k) clearance K102191
Creator: U.S. Food and Drug Administration
Published: 2011-05-02

Substantially Equivalent

Zhongshan Transtek Electronics Co., Ltd.

FDA 510(k) clearance K102191 for TRANSTEK GLASS BODY ANALYZER (4 models), Substantially Equivalent on 2011-05-02. Applicant: Zhongshan Transtek Electronics Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER
Applicant: Zhongshan Transtek Electronics Co., Ltd.
Product code: Code MNW
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 2010-08-03
Decision date: 2011-05-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chengdu, Sichuan, CN

Download summary PDF View on FDA.gov ↗

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