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FDA 510(k)

TRANSTEK BODY FAT ANALYZER

K-Number: K130311 · 2013-05-30

ApplicantGuangdong Transtek Medical Electronics Co., Ltd.
Decision Date2013-05-30
Product CodeMNW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSTEK BODY FAT ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2013-05-30 under 510(k) number K130311. The device is classified under product code MNW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSTEK BODY FAT ANALYZER?

TRANSTEK BODY FAT ANALYZER is a medical device that received FDA 510(k) clearance on 2013-05-30. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K130311.

When did TRANSTEK BODY FAT ANALYZER receive FDA 510(k) clearance?

TRANSTEK BODY FAT ANALYZER received FDA 510(k) clearance on 2013-05-30, under 510(k) number K130311.

Who is the listed applicant for TRANSTEK BODY FAT ANALYZER?

The FDA 510(k) record lists Guangdong Transtek Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSTEK BODY FAT ANALYZER?

The FDA product code for TRANSTEK BODY FAT ANALYZER is MNW.

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Other records listing Guangdong Transtek Medical Electronics Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243060TeleRPM Gen2 Blood Glucose Monitoring SystemK241351Blood Pressure Monitor (TMB-2092-G)K240832Blood Pressure Monitor (BBZ32-AA01)K240254Blood Pressure Monitor (TMB-2296-BT)K240102Blood Pressure Monitor (TMB-2287-B)K233130Blood Pressure Monitor

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Related Devices (Code: MNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.K130856BIA / VITALITY ANALYZERIpgdx, LLCK130777INBODYBiospace Corporation LimitedK130952PRECISION ONE LIFECARE; DETECTO; DETECTOPrecision One Lifecare, Ltd.K131394TRANSTEK GLASS BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.K122388SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514Seca GmbH & Co. KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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