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FDA 510(k)

IMPEDIMED - BODY COMPOSITION ANALYSIS

K-Number: K050395 · 2005-07-13

ApplicantImpedimed Pty , Ltd.
Decision Date2005-07-13
Product CodeMNW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPEDIMED - BODY COMPOSITION ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Impedimed Pty , Ltd.. It received FDA 510(k) clearance on 2005-07-13 under 510(k) number K050395. 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 IMPEDIMED - BODY COMPOSITION ANALYSIS?

IMPEDIMED - BODY COMPOSITION ANALYSIS is a medical device that received FDA 510(k) clearance on 2005-07-13. The listed applicant is Impedimed Pty , Ltd.. The 510(k) number is K050395.

When did IMPEDIMED - BODY COMPOSITION ANALYSIS receive FDA 510(k) clearance?

IMPEDIMED - BODY COMPOSITION ANALYSIS received FDA 510(k) clearance on 2005-07-13, under 510(k) number K050395.

Who is the listed applicant for IMPEDIMED - BODY COMPOSITION ANALYSIS?

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

What is the FDA product code for IMPEDIMED - BODY COMPOSITION ANALYSIS?

The FDA product code for IMPEDIMED - BODY COMPOSITION ANALYSIS is MNW.

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Other records listing Impedimed Pty , 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.

K080825IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400K050415IMPEDIMED-EXTRACELLULAR FLUID ANALYSISK052319IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7

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

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

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