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FDA 510(k)

SMART Bun-Yo-Matic CT

K-Number: K240642 · 2024-06-20

ApplicantDisior, Ltd.
Decision Date2024-06-20
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SMART Bun-Yo-Matic CT is a medical device manufactured by Disior, Ltd.. It received FDA 510(k) clearance on 2024-06-20 under approval number K240642. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMART Bun-Yo-Matic CT?

SMART Bun-Yo-Matic CT is a medical device that received FDA 510(k) clearance on 2024-06-20. It is manufactured by Disior, Ltd.. The 510(k) number is K240642.

When was SMART Bun-Yo-Matic CT approved by the FDA?

SMART Bun-Yo-Matic CT received FDA 510(k) clearance on 2024-06-20, under approval number K240642.

What company makes SMART Bun-Yo-Matic CT?

SMART Bun-Yo-Matic CT is manufactured by Disior, Ltd..

What is the FDA product code for SMART Bun-Yo-Matic CT?

The FDA product code for SMART Bun-Yo-Matic CT is QIH.

Other Devices by Disior, Ltd.

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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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