FDA 510(k) Application Details - K230698

Device Classification Name	Control, Pump Speed, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K230698
Device Name	Control, Pump Speed, Cardiopulmonary Bypass
Applicant	AMPTD Inc. 226 Lowell Street, Unit B16 Wilmington, MA 01887 US Other 510(k) Applications for this Company
Contact	John Sasso Other 510(k) Applications for this Contact
Regulation Number	870.4380   More FDA Info for this Regulation Number
Classification Product Code	DWA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2023
Decision Date	04/18/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review