FDA 510(k) Application Details - K250798

Device Classification Name	More FDA Info for this Device
510(K) Number	K250798
Device Name	Control-IQ+ technology
Applicant	Tandem Diabetes Care, Inc. 12400 High Bluff Drive San Diego, CA 92130 US Other 510(k) Applications for this Company
Contact	Miriam Chan 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	03/14/2025
Decision Date	05/21/2025
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