FDA 510(k) Application Details - K201214

Device Classification Name	More FDA Info for this Device
510(K) Number	K201214
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	Ashley Reynolds 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	05/05/2020
Decision Date	06/04/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review