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FDA 510(k)

ARTAssistant

K-Number: K250780 · 2025-12-05

ApplicantManteia Technologies Co., Ltd.
Decision Date2025-12-05
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTAssistant is a medical device manufactured by Manteia Technologies Co., Ltd.. It received FDA 510(k) clearance on 2025-12-05 under approval number K250780. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTAssistant?

ARTAssistant is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by Manteia Technologies Co., Ltd.. The 510(k) number is K250780.

When was ARTAssistant approved by the FDA?

ARTAssistant received FDA 510(k) clearance on 2025-12-05, under approval number K250780.

What company makes ARTAssistant?

ARTAssistant is manufactured by Manteia Technologies Co., Ltd..

What is the FDA product code for ARTAssistant?

The FDA product code for ARTAssistant is QKB.

Other Devices by Manteia Technologies Co., Ltd.

K223834AccuCheck K223724MOZI TPS K221706AccuContour K250696AccuCheck K251351AccuContour 4.0

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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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