FDA 510(k) Application Details - K200467

Device Classification Name	More FDA Info for this Device
510(K) Number	K200467
Device Name	Control-IQ Technology
Applicant	Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Michael Sarrasin 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	02/26/2020
Decision Date	06/16/2020
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