FDA 510(k) Application Details - K232224

Device Classification Name	More FDA Info for this Device
510(K) Number	K232224
Device Name	iLet« Dosing Decision Software
Applicant	Beta Bionics, Inc. 300 Baker Avenue, Suite 301 Concord, MA 01742 US Other 510(k) Applications for this Company
Contact	Liz Cooper Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2023
Decision Date	09/22/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review