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FDA 510(k)

BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5

K-Number: K053556 · 2006-08-31

ApplicantJawon Medical Co., Ltd.
Decision Date2006-08-31
Product CodeMNW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 is the device name listed in this FDA 510(k) record. The listed applicant is Jawon Medical Co., Ltd.. It received FDA 510(k) clearance on 2006-08-31 under 510(k) number K053556. 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 BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5?

BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 is a medical device that received FDA 510(k) clearance on 2006-08-31. The listed applicant is Jawon Medical Co., Ltd.. The 510(k) number is K053556.

When did BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 receive FDA 510(k) clearance?

BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 received FDA 510(k) clearance on 2006-08-31, under 510(k) number K053556.

Who is the listed applicant for BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5?

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

What is the FDA product code for BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5?

The FDA product code for BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 is MNW.

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Other records listing Jawon Medical 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.

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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.K130311TRANSTEK BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.

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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