FDA 510(k) Application Details - K212529

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K212529
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	Directed Systems Ltd 47-51 Norfolk Street Cambridge CB1 2LD GB Other 510(k) Applications for this Company
Contact	Mark S. Leaning Other 510(k) Applications for this Contact
Regulation Number	870.1435   More FDA Info for this Regulation Number
Classification Product Code	DXG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2021
Decision Date	11/23/2021
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