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FDA 510(k)

1CMR Pro

K-Number: K242062 · 2024-11-15

ApplicantMycardium AI Limited
Decision Date2024-11-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1CMR Pro is a medical device manufactured by Mycardium AI Limited. It received FDA 510(k) clearance on 2024-11-15 under approval number K242062. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1CMR Pro?

1CMR Pro is a medical device that received FDA 510(k) clearance on 2024-11-15. It is manufactured by Mycardium AI Limited. The 510(k) number is K242062.

When was 1CMR Pro approved by the FDA?

1CMR Pro received FDA 510(k) clearance on 2024-11-15, under approval number K242062.

What company makes 1CMR Pro?

1CMR Pro is manufactured by Mycardium AI Limited.

What is the FDA product code for 1CMR Pro?

The FDA product code for 1CMR Pro is LLZ.

Other Devices by Mycardium AI Limited

K250670EchoConfidence (USA)

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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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