FDA 510(k) Application Details - K210561

Device Classification Name	More FDA Info for this Device
510(K) Number	K210561
Device Name	Advisor Pro Platform
Applicant	DreaMed Diabetes Ltd. 5 Mota Gur St. Petah Tikva 4952701 IL Other 510(k) Applications for this Company
Contact	Inbal Beinglass Peled Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2021
Decision Date	09/28/2021
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