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FDA 510(k)

Eko Murmur Analysis Software (EMAS)

K-Number: K213794 · 2022-06-29

ApplicantEko Devices, Inc.
Decision Date2022-06-29
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Eko Murmur Analysis Software (EMAS) is the device name listed in this FDA 510(k) record. The listed applicant is Eko Devices, Inc.. It received FDA 510(k) clearance on 2022-06-29 under 510(k) number K213794. 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 Eko Murmur Analysis Software (EMAS)?

Eko Murmur Analysis Software (EMAS) is a medical device that received FDA 510(k) clearance on 2022-06-29. The listed applicant is Eko Devices, Inc.. The 510(k) number is K213794.

When did Eko Murmur Analysis Software (EMAS) receive FDA 510(k) clearance?

Eko Murmur Analysis Software (EMAS) received FDA 510(k) clearance on 2022-06-29, under 510(k) number K213794.

Who is the listed applicant for Eko Murmur Analysis Software (EMAS)?

The FDA 510(k) record lists Eko Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eko Murmur Analysis Software (EMAS)?

The FDA product code for Eko Murmur Analysis Software (EMAS) is DQD.

Related Clinical Trials

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.

NCT07087613Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECGRECRUITINGNCT05873387Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic StethoscopeRECRUITINGNCT07202104Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic StethoscopesWITHDRAWNNCT07227376Data Collection Using Eko Digital Devices in a Clinical SettingRECRUITINGNCT07270692Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial IntelligenceSUSPENDEDNCT07270744Data Collection Using Eko Devices in a Clinical SettingSUSPENDED

Other records listing Eko Devices, Inc. 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.

K230111CORE 500 Digital StethoscopeK200776Eko COREK192004Eko Analysis SoftwareK170874Eko Model E5 System (EME5), Eko DUO

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.K252284eMurmur Heart AICsd Labs

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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