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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
510(k) Number K250106
Device Name Signos Glucose Monitoring System
Applicant
Signos, Inc.
30011 Ivy Glenn Dr.
Suite 107
Laguna Niguel,  CA  92677
Applicant Contact Trevor Denbo
Correspondent
Signos, Inc.
30011 Ivy Glenn Dr.
Suite 107
Laguna Niguel,  CA  92677
Correspondent Contact Trevor Denbo
Regulation Number862.1355
Classification Product Code
SAF  
Date Received01/15/2025
Decision Date 03/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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