FDA 510(k) Application Details - K112273

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K112273
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	ACCUMED HEALTHCARE (SHANGHAI) INC. P.O. BOX 1277 MAPLE VALLEY, WA 98038 US Other 510(k) Applications for this Company
Contact	CYNTHIA (CINDY) GREEN 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	08/08/2011
Decision Date	11/22/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review