FDA 510(k) Application Details - K241078

Device Classification Name	More FDA Info for this Device
510(K) Number	K241078
Device Name	Tandem Mobi Insulin Pump with interoperable technology
Applicant	Tandem Diabetes Care, Inc. 12400 High Bluff Dr. San Diego, CA 92130 US Other 510(k) Applications for this Company
Contact	Jordan Barkhimer 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	04/19/2024
Decision Date	07/26/2024
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