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FDA 510(k)

Eko Model E5 System (EME5), Eko DUO

K-Number: K170874 · 2017-05-19

ApplicantEko Devices, Inc.
Decision Date2017-05-19
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Eko Model E5 System (EME5), Eko DUO 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 2017-05-19 under 510(k) number K170874. 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 Model E5 System (EME5), Eko DUO?

Eko Model E5 System (EME5), Eko DUO is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Eko Devices, Inc.. The 510(k) number is K170874.

When did Eko Model E5 System (EME5), Eko DUO receive FDA 510(k) clearance?

Eko Model E5 System (EME5), Eko DUO received FDA 510(k) clearance on 2017-05-19, under 510(k) number K170874.

Who is the listed applicant for Eko Model E5 System (EME5), Eko DUO?

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 Model E5 System (EME5), Eko DUO?

The FDA product code for Eko Model E5 System (EME5), Eko DUO 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.

NCT05873387Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic StethoscopeRECRUITINGNCT07087613Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECGRECRUITINGNCT07202104Improvement 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 StethoscopeK213794Eko Murmur Analysis Software (EMAS)K200776Eko COREK192004Eko Analysis Software

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

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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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