FDA 510(k) Application Details - DEN170043

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170043
Device Name	DreaMed Advisor Pro
Applicant	DreaMed Diabetes, Ltd. 3 Shimshon St. Petah Tikva, POB 3271 4952701 IL Other 510(k) Applications for this Company
Contact	Eran Atlas 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	08/17/2017
Decision Date	06/12/2018
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review