FDA 510(k) Application Details - K191407

Device Classification Name	More FDA Info for this Device
510(K) Number	K191407
Device Name	Novalung System
Applicant	Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Denise Oppermann 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	05/28/2019
Decision Date	02/21/2020
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