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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 K234070
Device Name Stelo Glucose Biosensor System
Applicant
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Applicant Contact Neeta Sharma
Correspondent
Dexcom, Inc.
6340 Sequence Dr.
San Diego,  CA  92121
Correspondent Contact Maryam Amini
Regulation Number862.1355
Classification Product Code
SAF  
Date Received12/22/2023
Decision Date 03/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT05263258
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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