Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Eko Devices, Inc.. It received FDA 510(k) clearance on 2020-01-15 under approval 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. It is manufactured by Eko Devices, Inc.. The 510(k) number is K192004.

When was Eko Analysis Software approved by the FDA?

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

What company makes Eko Analysis Software?

Eko Analysis Software is manufactured by Eko Devices, Inc..

What is the FDA product code for Eko Analysis Software?

The FDA product code for Eko Analysis Software is MWI.

Related Clinical Trials

NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT02091518 Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods ENROLLING_BY_INVITATION NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED NCT06366867 An Open Platform of Serious Games for Cognitive Intervention COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41714355 The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer. Abdominal radiology (New York) (2026) PMID: 41533310 Scoping review of regulatory transparency in AI-based radiology software: analysis of PMDA-approved SaMD products. Japanese journal of radiology (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026)

Other Devices by Eko Devices, Inc.

K170874Eko Model E5 System (EME5), Eko DUO K200776Eko CORE K213794Eko Murmur Analysis Software (EMAS) K230111CORE 500 Digital Stethoscope

Related Devices (Code: MWI)

K161909IQvitals ZoneMidmark Corporation K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien K151839AMC Health VitalCaregiving SystemAmc Health K160956LD-Oxi systemLd Technology, LLC K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation

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.

↑