FDA 510(k) Application Details - K192169

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K192169
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	Pulsion Medical Systems SE Hans-Riedl-Str. 17 Feldkirchen 85622 DE Other 510(k) Applications for this Company
Contact	Tobias Klaempfl 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	08/09/2019
Decision Date	04/30/2020
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