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FDA 510(k)

Kosmos

K-Number: K212100 · 2021-08-06

ApplicantEchoNous, Inc.
Decision Date2021-08-06
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Kosmos is a medical device manufactured by EchoNous, Inc.. It received FDA 510(k) clearance on 2021-08-06 under approval number K212100. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kosmos?

Kosmos is a medical device that received FDA 510(k) clearance on 2021-08-06. It is manufactured by EchoNous, Inc.. The 510(k) number is K212100.

When was Kosmos approved by the FDA?

Kosmos received FDA 510(k) clearance on 2021-08-06, under approval number K212100.

What company makes Kosmos?

Kosmos is manufactured by EchoNous, Inc..

What is the FDA product code for Kosmos?

The FDA product code for Kosmos is IYN.

Other Devices by EchoNous, Inc.

K181574Uscan K193518KOSMOS K233826Kosmos K242321Kosmos

Related Devices (Code: IYN)

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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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