FDA 510(k), K192004, Eko Analysis Software

FDA 510(k), K192004, Eko Analysis Software

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510(K) Number: K192004
Device Name: Eko Analysis Software
Manufacturer: Connor Landgraf
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
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