FDA 510(k) Application Details - K202145

Device Classification Name	More FDA Info for this Device
510(K) Number	K202145
Device Name	Bigfoot Unity Diabetes Management System
Applicant	Bigfoot Biomedical, Inc. 1820 McCarthy Blvd Milpitas, CA 95035 US Other 510(k) Applications for this Company
Contact	Kate Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QLG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2020
Decision Date	05/07/2021
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