Eko Devices, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CORE 500 Digital Stethoscope, Eko Murmur Analysis Software (EMAS), Eko CORE
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Eko Devices, Inc. Cardiovascular ✕
6 devices
Cleared
May 26, 2023
CORE 500 Digital Stethoscope
Cardiovascular
129d
Cleared
Jun 29, 2022
Eko Murmur Analysis Software (EMAS)
Cardiovascular
205d
Cleared
Apr 06, 2020
Eko CORE
Cardiovascular
12d
Cleared
Jan 15, 2020
Eko Analysis Software
Cardiovascular
173d
Cleared
May 19, 2017
Eko Model E5 System (EME5), Eko DUO
Cardiovascular
56d
Cleared
Aug 28, 2015
Eko Electronic Stethoscope System
Cardiovascular
102d