FDA 510(k) Application Details - DEN180058

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180058
Device Name	t:slim X2 insulin pump with interoperable 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	QFG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/2018
Decision Date	02/14/2019
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review