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FDA 510(k) Applications Submitted by Eko Devices, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K200776
03/25/2020
Eko CORE
Eko Devices, Inc.
K170874
03/24/2017
Eko Model E5 System (EME5), Eko DUO
Eko Devices, Inc.
K151319
05/18/2015
Eko Electronic Stethoscope System
Eko Devices, Inc.
K213794
12/06/2021
Eko Murmur Analysis Software (EMAS)
Eko Devices, Inc.
K230111
01/17/2023
CORE 500 Digital Stethoscope
Eko Devices, Inc.
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