TRANSTEK— 510(k) K112932

Name: FDA 510(k) clearance K112932
Creator: U.S. Food and Drug Administration
Published: 2011-11-01

Substantially Equivalent

Zhongshan Transtek Electronics Co., Ltd.

FDA 510(k) clearance K112932 for TRANSTEK, Substantially Equivalent on 2011-11-01. Applicant: Zhongshan Transtek Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhongshan Transtek Electronics Co., Ltd.
Product code: Code MNW
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 2011-10-03
Decision date: 2011-11-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Chengdu, Sichuan, CN

Download summary PDF View on FDA.gov ↗

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