FDA 510(k) Application Details - K231826

Device Classification Name	More FDA Info for this Device
510(K) Number	K231826
Device Name	Omnipod 5 ACE Pump
Applicant	Insulet Corporation 100 Nagog Park Acton, MA 01720 US Other 510(k) Applications for this Company
Contact	Maria Brower 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	06/21/2023
Decision Date	10/18/2023
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