FDA 510(k) Application Details - K172259

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K172259
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	Marc Bergenthal 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	07/27/2017
Decision Date	01/18/2018
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