FDA 510(k) Application Details - K080789

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K080789
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. 6367 BANCROFT WAY SAN JOSE, CA 95129 US Other 510(k) Applications for this Company
Contact	JIANYAO WU 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	03/20/2008
Decision Date	04/03/2008
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	Y
Expedited Review