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FDA 510(k)

eMurmur Heart AI

K-Number: K252284 · 2025-12-19

ApplicantCsd Labs
Decision Date2025-12-19
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

eMurmur Heart AI is a medical device manufactured by Csd Labs. It received FDA 510(k) clearance on 2025-12-19 under approval number K252284. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eMurmur Heart AI?

eMurmur Heart AI is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Csd Labs. The 510(k) number is K252284.

When was eMurmur Heart AI approved by the FDA?

eMurmur Heart AI received FDA 510(k) clearance on 2025-12-19, under approval number K252284.

What company makes eMurmur Heart AI?

eMurmur Heart AI is manufactured by Csd Labs.

What is the FDA product code for eMurmur Heart AI?

The FDA product code for eMurmur Heart AI is DQD.

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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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