FDA 510(k) K192004, Eko Analysis Software, by Eko Devices, Inc.

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510(K) Number: K192004 Device Name: Eko Analysis Software Manufacturer: Eko Devices, Inc. Device Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Regulation Number: MWI Classification Product Code: KXA Date Received: 07/26/2019 Decision Date: 01/15/2020 Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular Show more