FDA 510(k) Application Details - K203689

Device Classification Name	More FDA Info for this Device
510(K) Number	K203689
Device Name	Tidepool Loop
Applicant	Tidepool Project 3340 Hillview Ave Palo Alto, CA 94304 US Other 510(k) Applications for this Company
Contact	Howard Look 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	12/17/2020
Decision Date	01/23/2023
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