TRANSTEK BODY FAT ANALYZER— 510(k) K130311

Name: FDA 510(k) clearance K130311
Creator: U.S. Food and Drug Administration
Published: 2013-05-30

Substantially Equivalent

Guangdong Transtek Medical Electronics Co., Ltd.

FDA 510(k) clearance K130311 for TRANSTEK BODY FAT ANALYZER, Substantially Equivalent on 2013-05-30. Applicant: Guangdong Transtek Medical Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangdong Transtek Medical Electronics Co., Ltd.
Product code: Code MNW
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 2013-02-08
Decision date: 2013-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chengdu, Sichuan, 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.