FDA 510(k) Application Details - K173591

Device Classification Name	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K173591
Device Name	Monitor, Blood-Gas, On-Line, 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	870.4330   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	11/21/2017
Decision Date	03/28/2018
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