FDA.reportPublic FDA data

SIGNOS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30410007943041000794SIGNOS, INC.1N2026-01-0130011 Ivy Glenn Dr Ste 107 Laguna Niguel CA US 92677

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3427771879946702K250106Signos Glucose Monitoring SystemSAF2025-03-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SAF12025-03-21

PMN#

SpeqT

2016-03-21

Signostics Limited

SpeqRT

2015-09-03

Signostics Limited

GUDID#

Signos Glucose Management System - The Signos Glucose Monitoring System is an over-the-counter (OTC) mobile device application that receives data from an integrated Continuous Glucose Monitor (iCGM) sensor and is intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Signos Glucose Monitoring System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Signos Glucose Monitoring System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursions. This information may be useful in helping users to maintain a healthy weight.The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.

SIGNOS, INC.

2026-02-24