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FDA 510(k)

IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS

K-Number: K130338 · 2013-05-31

ApplicantImpediMed Limited
Decision Date2013-05-31
Product CodeOBH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is ImpediMed Limited. It received FDA 510(k) clearance on 2013-05-31 under 510(k) number K130338. 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 - BIS EXTRA CELLULAR FLUID ANALYSIS?

IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS is a medical device that received FDA 510(k) clearance on 2013-05-31. The listed applicant is ImpediMed Limited. The 510(k) number is K130338.

When did IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS receive FDA 510(k) clearance?

IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS received FDA 510(k) clearance on 2013-05-31, under 510(k) number K130338.

Who is the listed applicant for IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS?

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 - BIS EXTRA CELLULAR FLUID ANALYSIS?

The FDA product code for IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS is OBH.

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Other records listing ImpediMed Limited as applicant

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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

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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 LimitedK100811IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400ImpediMed 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.

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