Eko Devices, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

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