FDA 510(k) Application Details - K122361

Device Classification Name	More FDA Info for this Device
510(K) Number	K122361
Device Name	T:CONNECT DATA MANAGEMENT SYSTEM
Applicant	TANDEM DIABETES CARE, INC. 11045 Roselle St Ste 200 San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	DON CANAL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2012
Decision Date	02/22/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review