FDA 510(k) Application Details - K191679

Device Classification Name	More FDA Info for this Device
510(K) Number	K191679
Device Name	Omnipod DASH Insulin Management System with interoperable technology
Applicant	Insulet Corporation 100 Nagog Park Acton, MA 01720 US Other 510(k) Applications for this Company
Contact	Julie Perkins 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	06/24/2019
Decision Date	09/20/2019
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