FDA 510(k) Application Details - K203774

Device Classification Name	More FDA Info for this Device
510(K) Number	K203774
Device Name	SmartAdjust technology
Applicant	Insulet Corporation 100 Nagog Park Acton, MA 01720 US Other 510(k) Applications for this Company
Contact	Alexander Hamad Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2020
Decision Date	01/27/2022
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