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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interoperable Automated Glycemic Controller
510(k) Number K232224
Device Name iLet® Dosing Decision Software
Applicant
Beta Bionics, Inc.
300 Baker Ave., Suite 301
Concord,  MA  01742
Applicant Contact Liz Cooper
Correspondent
Beta Bionics, Inc.
300 Baker Ave., Suite 301
Concord,  MA  01742
Correspondent Contact Liz Cooper
Regulation Number862.1356
Classification Product Code
QJI  
Date Received07/27/2023
Decision Date 09/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT04200313
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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