FDA 510(k) Application Details - K182110

Device Classification Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K182110
Device Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Applicant	Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103 US Other 510(k) Applications for this Company
Contact	Bryan K. Hann 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	08/06/2018
Decision Date	11/02/2018
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