FDA 510(k) Application Details - K202154

Device Classification Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K202154
Device Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Applicant	LivaNova Deutschland GmbH Lindberghstr. 25 Munich 80939 DE Other 510(k) Applications for this Company
Contact	Mattia Ronchetti Other 510(k) Applications for this Contact
Regulation Number	870.4330   More FDA Info for this Regulation Number
Classification Product Code	DRY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2020
Decision Date	04/01/2021
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