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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 the device name listed in this FDA 510(k) record. The listed applicant is Csd Labs. It received FDA 510(k) clearance on 2025-12-19 under 510(k) 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. The listed applicant is Csd Labs. The 510(k) number is K252284.

When did eMurmur Heart AI receive FDA 510(k) clearance?

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

Who is the listed applicant for eMurmur Heart AI?

The FDA 510(k) record lists Csd Labs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eMurmur Heart AI?

The FDA product code for eMurmur Heart AI is DQD.

Other records listing Csd Labs as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220766eMurmur Heart AIK181988eMurmur ID

Related Devices (Code: DQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)Shanghai Hulu Devices Co., Ltd.K261694CORE 300 Digital StethoscopeEko Health, Inc.K252915AiSteth®Ai Health Highway India Pvt., Ltd.K252089Tyto Stethoscope (G3)Tyto Care , Ltd.K252076Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.K252595Stethophone ProSparrow Acoustics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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