FDA 510(k) Application Details - K232926

Device Classification Name	More FDA Info for this Device
510(K) Number	K232926
Device Name	Novalung ultimate kit (US)
Applicant	Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Amelia Huynh Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2023
Decision Date	04/15/2024
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