FDA 510(k) Application Details - K173834

Device Classification Name	Console, Heart-Lung Machine, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K173834
Device Name	Console, Heart-Lung Machine, Cardiopulmonary Bypass
Applicant	Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester GL2 9QL GB Other 510(k) Applications for this Company
Contact	Mark Drain Other 510(k) Applications for this Contact
Regulation Number	870.4220   More FDA Info for this Regulation Number
Classification Product Code	DTQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2017
Decision Date	05/25/2018
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