Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400

K-Number: K100811 · 2011-11-04

ApplicantImpediMed Limited
Decision Date2011-11-04
Product CodeOBH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 is the device name listed in this FDA 510(k) record. The listed applicant is ImpediMed Limited. It received FDA 510(k) clearance on 2011-11-04 under 510(k) number K100811. The device is classified under product code OBH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400?

IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 is a medical device that received FDA 510(k) clearance on 2011-11-04. The listed applicant is ImpediMed Limited. The 510(k) number is K100811.

When did IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 receive FDA 510(k) clearance?

IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 received FDA 510(k) clearance on 2011-11-04, under 510(k) number K100811.

Who is the listed applicant for IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400?

The FDA 510(k) record lists ImpediMed Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400?

The FDA product code for IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 is OBH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing ImpediMed Limited 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.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)K232089SOZO ProK230530SOZO ProK230531SOZO ProK203473SOZO

View all 13 devices →

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

View on FDA Database →

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

↑