FDA 510(k) Application Details - K171620

Device Classification Name	Probe, Thermodilution   More FDA Info for this Device
510(K) Number	K171620
Device Name	Probe, Thermodilution
Applicant	PULSION Medical Systems SE Hans-Riedl-Strasse 17 Feldkirchen 85622 DE Other 510(k) Applications for this Company
Contact	Ingrid Rohm Other 510(k) Applications for this Contact
Regulation Number	870.1915   More FDA Info for this Regulation Number
Classification Product Code	KRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2017
Decision Date	02/21/2018
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