FDA 510(k) Application Details - K223213

Device Classification Name	More FDA Info for this Device
510(K) Number	K223213
Device Name	Tandem Mobi 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 Schneider 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	10/17/2022
Decision Date	07/10/2023
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