FDA 510(k) Application Details - K190927

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K190927
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Rudolf Riester GmbH P.O. Box 35 Bruckstrasse 31 Jungingen D-72417 DE Other 510(k) Applications for this Company
Contact	Vivi Ding Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/09/2019
Decision Date	06/24/2019
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