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FDA 510(k)

IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400

K-Number: K080825 · 2008-10-03

ApplicantImpedimed Pty , Ltd.
Decision Date2008-10-03
Product CodeOBH
Advisory CommitteeCV
DecisionUnknown

Device Summary

IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 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 2008-10-03 under 510(k) number K080825. The device is classified under product code OBH. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400?

IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 is a medical device that received FDA 510(k) clearance on 2008-10-03. The listed applicant is Impedimed Pty , Ltd.. The 510(k) number is K080825.

When did IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 receive FDA 510(k) clearance?

IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 received FDA 510(k) clearance on 2008-10-03, under 510(k) number K080825.

Who is the listed applicant for IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400?

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 EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400?

The FDA product code for IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 is OBH.

Related Clinical Trials

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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.

K050415IMPEDIMED-EXTRACELLULAR FLUID ANALYSISK052319IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7K050395IMPEDIMED - BODY COMPOSITION ANALYSIS

Related Devices (Code: OBH)

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.

K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed LimitedK230530SOZO ProImpediMed LimitedK220557MoistureMeterD Compact, LymphScannerDelfin Technologies, Ltd.K180126SOZOImpediMed LimitedK172122SOZOImpediMed LimitedK130338IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSISImpediMed Limited

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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