FDA 510(k) Application Details - K190693

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K190693
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Omron Healthcare, Inc. 1925 West Field Court, Suite 100 Lake Forest, IL 60045 US Other 510(k) Applications for this Company
Contact	Renee Thornborough 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	03/18/2019
Decision Date	04/17/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review