SIGNOS, INC.

FDA Device Registration & Listing · Laguna Niguel, CA, US · Registration 3041000794

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3041000794
FEI Number
3041000794
Entity Name
SIGNOS, INC.
City/State/Country
Laguna Niguel, CA, US
Establishment Address
30011 Ivy Glenn Dr Ste 107, Laguna Niguel, CA 92677, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Signos, Inc. (Owner Number: 10094001)
Owner / Operator Contact Address
30011 Ivy Glenn, Suite 107, Laguna Niguel, CA 92677, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250106
PMA Number
N/A

All Registered Proprietary Names

Signos Signos Glucose Management System Signos GMS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter Clinical Chemistry Class 2 862.1355 2025-09-08

Official Correspondent

Trevor Denbo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Signos, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3041000794. Last updated year: 2026. Please use registration number 3041000794 when referencing this establishment in official correspondence.
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