FDA 510(k)

Signos Glucose Monitoring System

K-Number: K250106 · 2025-03-21

Decision Date2025-03-21

Product CodeSAF

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Signos Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Signos, Inc.. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K250106. The device is classified under product code SAF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Signos Glucose Monitoring System?

Signos Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Signos, Inc.. The 510(k) number is K250106.

When did Signos Glucose Monitoring System receive FDA 510(k) clearance?

Signos Glucose Monitoring System received FDA 510(k) clearance on 2025-03-21, under 510(k) number K250106.

Who is the listed applicant for Signos Glucose Monitoring System?

The FDA 510(k) record lists Signos, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Signos Glucose Monitoring System?

The FDA product code for Signos Glucose Monitoring System is SAF.

Related Devices (Code: SAF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261359Stelo Glucose Biosensor SystemDexcom, Inc.K233655Lingo Glucose SystemAbbott K234070Stelo Glucose Biosensor SystemDexcom, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.