SIGNOS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3041000794	3041000794	SIGNOS, INC.	1	N	2026-01-01	30011 Ivy Glenn Dr Ste 107 Laguna Niguel CA US 92677

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
342777	1879946702	K250106	Signos Glucose Monitoring System	SAF	2025-03-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
SAF	1	2025-03-21

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