FDA 510(k) Application Details - K082542

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K082542
Device Name	Blood Pressure Cuff
Applicant	CARDICARE COMPANY, LTD. 9 YAN AN ROAD, WU SHAN PLAZA TOWN, UNIT 7003 HANGZHOU, ZHEJIANG 310002 CN Other 510(k) Applications for this Company
Regulation Number	870.1120   More FDA Info for this Regulation Number
Classification Product Code	DXQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2008
Decision Date	09/17/2008
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