FDA 510(k) Application Details - K220272

Device Classification Name	More FDA Info for this Device
510(K) Number	K220272
Device Name	cobas pulse blood glucose monitoring system
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Teresa Carrow Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2022
Decision Date	04/26/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review