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Eko Devices, Inc.

FDA Regulatory Profile

Eko Devices, Inc. has 0 FDA recalls, 0 inspections, 6 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
May 26, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances6Oct 4, 2026Not statedCurrent
Inspections0Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K230111CORE 500 Digital StethoscopeMay 26, 2023
K213794Eko Murmur Analysis Software (EMAS)Jun 29, 2022
K200776Eko COREApr 6, 2020
K192004Eko Analysis SoftwareJan 15, 2020
K170874Eko Model E5 System (EME5), Eko DUOMay 19, 2017
K151319Eko Electronic Stethoscope SystemAug 28, 2015

FDA data resources