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FDA 510(k)

Us2.ca

K-Number: K250151 · 2025-06-20

ApplicantEko.Ai Pte Ltd. D/B/A Us2.Ai
Decision Date2025-06-20
Product CodeSDJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Us2.ca is a medical device manufactured by Eko.Ai Pte Ltd. D/B/A Us2.Ai. It received FDA 510(k) clearance on 2025-06-20 under approval number K250151. The device is classified under product code SDJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Us2.ca?

Us2.ca is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Eko.Ai Pte Ltd. D/B/A Us2.Ai. The 510(k) number is K250151.

When was Us2.ca approved by the FDA?

Us2.ca received FDA 510(k) clearance on 2025-06-20, under approval number K250151.

What company makes Us2.ca?

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

What is the FDA product code for Us2.ca?

The FDA product code for Us2.ca is SDJ.

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

K210791Us2.v1 K233676Us2.v2

Related Devices (Code: SDJ)

K240860EchoGo Amyloidosis (1.0)Ultromics Limited K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation

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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