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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