FDA 510(k) Application Details - K193483

Device Classification Name	More FDA Info for this Device
510(K) Number	K193483
Device Name	Basal-IQ Technology
Applicant	Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Trevor J Dendo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2019
Decision Date	02/28/2020
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