FDA 510(k) Application Details - K190955

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K190955
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	Directed Systems Ltd St John's Innovation Centre, Cowley Road Cambridge CB4 0WS 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	04/11/2019
Decision Date	11/27/2019
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