FDA 510(k) Application Details - K212657

Device Classification Name	Controller, Temperature, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K212657
Device Name	Controller, Temperature, Cardiopulmonary Bypass
Applicant	Spectrum Medical Ltd. Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester GL29QL GB Other 510(k) Applications for this Company
Contact	Colleen Powell Other 510(k) Applications for this Contact
Regulation Number	870.4250   More FDA Info for this Regulation Number
Classification Product Code	DWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2021
Decision Date	05/06/2022
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