Yumizen H2500
K-Number: K232946 · 2024-05-21
ApplicantHORIBA ABX SAS
Decision Date2024-05-21
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
Yumizen H2500 is a medical device manufactured by HORIBA ABX SAS. It received FDA 510(k) clearance on 2024-05-21 under approval number K232946. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Yumizen H2500?
Yumizen H2500 is a medical device that received FDA 510(k) clearance on 2024-05-21. It is manufactured by HORIBA ABX SAS. The 510(k) number is K232946.
When was Yumizen H2500 approved by the FDA?
Yumizen H2500 received FDA 510(k) clearance on 2024-05-21, under approval number K232946.
What company makes Yumizen H2500?
Yumizen H2500 is manufactured by HORIBA ABX SAS.
What is the FDA product code for Yumizen H2500?
The FDA product code for Yumizen H2500 is GKZ.
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K192028Yumizen C1200 CRP
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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.