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510(k) K250106

Device
Signos Glucose Monitoring System
Applicant
Signos, Inc.
510(k) number
K250106
Product code
SAF
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-21
Date received
2025-01-15
Regulation
862.1355
Classification name
Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Trevor Denbo
Address
30011 Ivy Glenn Dr. Suite 107 Laguna Niguel CA US 92677 92677

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SAF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261359Stelo Glucose Biosensor SystemDexcom, Inc.2026-05-21
K233655Lingo Glucose SystemAbbott2024-05-29
K234070Stelo Glucose Biosensor SystemDexcom, Inc.2024-03-05