FDA 510(k) Application Details - K133588

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K133588
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	FORA CARE INC. 6F, NO.127, WUGONG 2ND RD WUGU DISTRICT NEW TAIPEI CITY 24888 TW Other 510(k) Applications for this Company
Contact	Sharon Peng 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	11/21/2013
Decision Date	04/25/2014
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