FDA 510(k) Application Details - K233861

Device Classification Name	More FDA Info for this Device
510(K) Number	K233861
Device Name	Libre Rio Continuous Glucose Monitoring System
Applicant	Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502 US Other 510(k) Applications for this Company
Contact	Tenzin Ngadon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2023
Decision Date	06/07/2024
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