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 a medical device manufactured by ImpediMed Limited. It received FDA 510(k) clearance on 2020-10-02 under approval 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. It is manufactured by ImpediMed Limited. The 510(k) number is K193410.
When was SOZO Body Fluid Analyzer approved by the FDA?
SOZO Body Fluid Analyzer received FDA 510(k) clearance on 2020-10-02, under approval number K193410.
What company makes SOZO Body Fluid Analyzer?
SOZO Body Fluid Analyzer is manufactured by ImpediMed Limited.
What is the FDA product code for SOZO Body Fluid Analyzer?
The FDA product code for SOZO Body Fluid Analyzer is DSB.
Related Clinical Trials
Other Devices by ImpediMed Limited
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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.