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FDA 510(k)

Yumizen H550

K-Number: K260781 · 2026-09-14

ApplicantHORIBA ABX SAS
Decision Date2026-09-14
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Yumizen H550 is the device name listed in this FDA 510(k) record. The listed applicant is HORIBA ABX SAS. It received FDA 510(k) clearance on 2026-09-14 under 510(k) number K260781. 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 H550?

Yumizen H550 is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is HORIBA ABX SAS. The 510(k) number is K260781.

When did Yumizen H550 receive FDA 510(k) clearance?

Yumizen H550 received FDA 510(k) clearance on 2026-09-14, under 510(k) number K260781.

Who is the listed applicant for Yumizen H550?

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

What is the FDA product code for Yumizen H550?

The FDA product code for Yumizen H550 is GKZ.

Other records listing HORIBA ABX SAS as applicant

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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.

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