FDA 510(k) Application Details - K232722

Device Classification Name	More FDA Info for this Device
510(K) Number	K232722
Device Name	endo.digital Platform
Applicant	DreaMed Diabetes Ltd 14 Kaplan St, POB 3271 Petah Tikva 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	09/05/2023
Decision Date	10/03/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review