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FDA 510(k)

Eko Analysis Software

K-Number: K192004 · 2020-01-15

ApplicantEko Devices, Inc.
Decision Date2020-01-15
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Eko Analysis Software 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 2020-01-15 under 510(k) number K192004. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eko Analysis Software?

Eko Analysis Software is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Eko Devices, Inc.. The 510(k) number is K192004.

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

Eko Analysis Software received FDA 510(k) clearance on 2020-01-15, under 510(k) number K192004.

Who is the listed applicant for Eko Analysis Software?

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 Analysis Software?

The FDA product code for Eko Analysis Software is MWI.

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 StethoscopeK213794Eko Murmur Analysis Software (EMAS)K200776Eko COREK170874Eko Model E5 System (EME5), Eko DUO

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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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