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FDA 510(k)

Koios DS

K-Number: K242130 · 2024-11-15

ApplicantKoios Medical, Inc.
Decision Date2024-11-15
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Koios DS is a medical device manufactured by Koios Medical, Inc.. It received FDA 510(k) clearance on 2024-11-15 under approval number K242130. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Koios DS?

Koios DS is a medical device that received FDA 510(k) clearance on 2024-11-15. It is manufactured by Koios Medical, Inc.. The 510(k) number is K242130.

When was Koios DS approved by the FDA?

Koios DS received FDA 510(k) clearance on 2024-11-15, under approval number K242130.

What company makes Koios DS?

Koios DS is manufactured by Koios Medical, Inc..

What is the FDA product code for Koios DS?

The FDA product code for Koios DS is POK.

Other Devices by Koios Medical, Inc.

K190442Koios DS for Breast K212616Koios DS

Related Devices (Code: POK)

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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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