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FDA 510(k)

Koios DS

K-Number: K212616 · 2021-12-16

ApplicantKoios Medical, Inc.
Decision Date2021-12-16
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 2021-12-16 under approval number K212616. 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 2021-12-16. It is manufactured by Koios Medical, Inc.. The 510(k) number is K212616.

When was Koios DS approved by the FDA?

Koios DS received FDA 510(k) clearance on 2021-12-16, under approval number K212616.

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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