Eko Analysis Software

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

Eko Devices Inc

The following data is part of a premarket notification filed by Eko Devices Inc with the FDA for Eko Analysis Software.

Pre-market Notification Details

Device IDK192004
510k NumberK192004
Device Name:Eko Analysis Software
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant Eko Devices Inc 2600 10TH ST,SUITE 260 Berkeley,  CA  94710
ContactConnor Landgraf
CorrespondentYarmela Pavlovic
Manatt, Phelps & Phillips, LLP One Embarcadero Center 30th Floor San Francisco,  CA  94111
Product CodeMWI  
Subsequent Product CodeDPS
Subsequent Product CodeDQD
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-26
Decision Date2020-01-15

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