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FDA 510(k)

RUS

K-Number: K233457 · 2024-07-12

ApplicantHutom, Inc.
Decision Date2024-07-12
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RUS is a medical device manufactured by Hutom, Inc.. It received FDA 510(k) clearance on 2024-07-12 under approval number K233457. 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 RUS?

RUS is a medical device that received FDA 510(k) clearance on 2024-07-12. It is manufactured by Hutom, Inc.. The 510(k) number is K233457.

When was RUS approved by the FDA?

RUS received FDA 510(k) clearance on 2024-07-12, under approval number K233457.

What company makes RUS?

RUS is manufactured by Hutom, Inc..

What is the FDA product code for RUS?

The FDA product code for RUS is QIH.

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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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