FDA 510(k) Application Details - K233216

Device Classification Name	More FDA Info for this Device
510(K) Number	K233216
Device Name	CLEWICU System
Applicant	Clew Medical Ltd. 5 Hamelecha Street Poleg 4250540 IL Other 510(k) Applications for this Company
Contact	Avidgor 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	09/28/2023
Decision Date	01/13/2024
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