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FDA 510(k)

SOZO Body Fluid Analyzer

K-Number: K193410 · 2020-10-02

ApplicantImpediMed Limited
Decision Date2020-10-02
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOZO Body Fluid Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is ImpediMed Limited. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K193410. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOZO Body Fluid Analyzer?

SOZO Body Fluid Analyzer is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is ImpediMed Limited. The 510(k) number is K193410.

When did SOZO Body Fluid Analyzer receive FDA 510(k) clearance?

SOZO Body Fluid Analyzer received FDA 510(k) clearance on 2020-10-02, under 510(k) number K193410.

Who is the listed applicant for SOZO Body Fluid Analyzer?

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 SOZO Body Fluid Analyzer?

The FDA product code for SOZO Body Fluid Analyzer is DSB.

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.

K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)K232089SOZO ProK230531SOZO ProK230530SOZO ProK203473SOZOK190529SOZO

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Related Devices (Code: DSB)

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.

K250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.K211585Bodyport Cardiac ScaleBodyport, Inc.

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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