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FDA 510(k)

ART.1-US

K-Number: K253078 · 2026-05-14

ApplicantSeetreat Pty, Ltd.
Decision Date2026-05-14
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ART.1-US is a medical device manufactured by Seetreat Pty, Ltd.. It received FDA 510(k) clearance on 2026-05-14 under approval number K253078. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ART.1-US?

ART.1-US is a medical device that received FDA 510(k) clearance on 2026-05-14. It is manufactured by Seetreat Pty, Ltd.. The 510(k) number is K253078.

When was ART.1-US approved by the FDA?

ART.1-US received FDA 510(k) clearance on 2026-05-14, under approval number K253078.

What company makes ART.1-US?

ART.1-US is manufactured by Seetreat Pty, Ltd..

What is the FDA product code for ART.1-US?

The FDA product code for ART.1-US is MUJ.

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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