FDA.reportPublic FDA data

Eko Health, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30116512303011651230Eko Health, Inc.1N2026-01-012100 Powell St, Suite 300 Emeryville CA US 94608

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1829501432856925K251494Eko Foundation Analysis Software with Transformers (EFAST)DQD2025-08-12
1829501953985243K233609CORE 500 Digital StethoscopeDQD2024-03-28
1829501604524823K233409Eko Low Ejection Fraction Tool (ELEFT)QYE2024-03-28
1829501659949177K230111CORE 500 Digital StethoscopeDQD2023-05-26
1829501484556953K213794Eko Murmur Analysis Software (EMAS)DQD2022-06-29
1829501828701555K200776Eko COREDQD2020-04-06
1829501562737996K192004Eko Analysis SoftwareMWI2020-01-15
1829501907643404K170874Eko Model E5 System (EME5), Eko DUODQD2017-05-19
1829501937597156K151319Eko Electronic Stethoscope SystemDQD2015-08-28
1829501885394282

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQD82025-08-12
QYE12024-03-28
MWI12020-01-15

PMN#