FDA.reportPublic FDA data

EPITEL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146923313014692331EPITEL1N2026-01-01465 South 400 East Suite 250 Salt Lake City UT US 84111

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2954481497579803K243185REMI Remote EEG Monitoring SystemOMC2025-03-21
2954481807748284K231779REMI AI Discrete Detection ModuleOMB2024-01-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OMC12025-03-21
OMB12024-01-03