FDA 510(k) Application Details - K232788

Device Classification Name	Control, Pump Speed, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K232788
Device Name	Control, Pump Speed, Cardiopulmonary Bypass
Applicant	Inspira Technologies Oxy B.H.N Ltd. 2 Ha-Tidhar St. Ra'anana 4366504 IL Other 510(k) Applications for this Company
Contact	Dganit Litinsky Other 510(k) Applications for this Contact
Regulation Number	870.4380   More FDA Info for this Regulation Number
Classification Product Code	DWA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2023
Decision Date	05/24/2024
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