FDA 510(k) Application Details - K222888

Device Classification Name	More FDA Info for this Device
510(K) Number	K222888
Device Name	BlueStar CGM insulin dose calculator
Applicant	Welldoc, Inc. 10221 Wincopin Circle, Ste #150 Columbia, MD 21044 US Other 510(k) Applications for this Company
Contact	Ian Cadieux Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2022
Decision Date	08/11/2023
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