FDA 510(k) Application Details - K200717

Device Classification Name	More FDA Info for this Device
510(K) Number	K200717
Device Name	CLEWICU System (ClewICUServer and ClewICUnitor)
Applicant	CLEW Medical Ltd. 5 Hamelacha St. Netanya 4206002 IL Other 510(k) Applications for this Company
Contact	Avigdor Faians Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2020
Decision Date	01/09/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review