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FDA 510(k)

EchoConfidence (USA)

K-Number: K250670 · 2025-06-30

ApplicantMycardium AI Limited
Decision Date2025-06-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoConfidence (USA) is a medical device manufactured by Mycardium AI Limited. It received FDA 510(k) clearance on 2025-06-30 under approval number K250670. 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 EchoConfidence (USA)?

EchoConfidence (USA) is a medical device that received FDA 510(k) clearance on 2025-06-30. It is manufactured by Mycardium AI Limited. The 510(k) number is K250670.

When was EchoConfidence (USA) approved by the FDA?

EchoConfidence (USA) received FDA 510(k) clearance on 2025-06-30, under approval number K250670.

What company makes EchoConfidence (USA)?

EchoConfidence (USA) is manufactured by Mycardium AI Limited.

What is the FDA product code for EchoConfidence (USA)?

The FDA product code for EchoConfidence (USA) is QIH.

Other Devices by Mycardium AI Limited

K2420621CMR Pro

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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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