FDA 510(k) Application Details - K233755

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K233755
Device Name	Computer, Diagnostic, Programmable
Applicant	B-Secur Limited 11th Floor, City Quays 3 92 Donegall Quay Belfast BT1 3FE GB Other 510(k) Applications for this Company
Contact	Cameron Moore Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2023
Decision Date	08/16/2024
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