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FDA 510(k)

Us2.v1

K-Number: K210791 · 2021-07-27

ApplicantEko.Ai Pte Ltd. D/B/A Us2.Ai
Decision Date2021-07-27
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Us2.v1 is a medical device manufactured by Eko.Ai Pte Ltd. D/B/A Us2.Ai. It received FDA 510(k) clearance on 2021-07-27 under approval number K210791. 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 Us2.v1?

Us2.v1 is a medical device that received FDA 510(k) clearance on 2021-07-27. It is manufactured by Eko.Ai Pte Ltd. D/B/A Us2.Ai. The 510(k) number is K210791.

When was Us2.v1 approved by the FDA?

Us2.v1 received FDA 510(k) clearance on 2021-07-27, under approval number K210791.

What company makes Us2.v1?

Us2.v1 is manufactured by Eko.Ai Pte Ltd. D/B/A Us2.Ai.

What is the FDA product code for Us2.v1?

The FDA product code for Us2.v1 is QIH.

Other Devices by Eko.Ai Pte Ltd. D/B/A Us2.Ai

K233676Us2.v2 K250151Us2.ca

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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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