K-number	K220916
Device name	iLet® Dosing Decision Software
Applicant	Beta Bionics, Inc.
Product code	QJI
Device class	Class II
Decision date	May 19, 2023
Decision	Substantially Equivalent
Regulation	862.1356

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Source

View the full FDA submission: accessdata.fda.gov

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iLet® Dosing Decision Software

Everything you need for a 510(k) submission. Nothing you don't.