FDA 510(k) Application Details - K243852

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K243852
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	Elfi-Tech Ltd. 150 Derech Menachem Begin Tel Aviv 6492105 IL Other 510(k) Applications for this Company
Contact	Orly Maor Other 510(k) Applications for this Contact
Regulation Number	870.2100   More FDA Info for this Regulation Number
Classification Product Code	DPW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2024
Decision Date	04/14/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review