FDA.reportPublic FDA data

EPITEL

Matched from indexed company URL: Epitel, Inc.

FDA Registration(s)#

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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860005388103REMI - REMI Wireless EEG Sensor(801)497-6297support@epitel.com
00860005388110REMI - REMI EEG Monitoring Software (Healthcare Facility module) - v. 2.x.x.x(801)497-6297support@epitel.com
00860005388158REMI - REMI-Cloud(801)497-6297support@epitel.com

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

PMN#

REMI

2021-03-29

Epitel, Inc.

GUDID#