FDA 510(k) Application Details - K053006

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K053006
Device Name	Blood Pressure Cuff
Applicant	ROSSMAX INTERNATIONL LTD. 12F, NO. 189, KANG CHIEN RD. TAIPEI 114 TW Other 510(k) Applications for this Company
Contact	YOLANDA LIN Other 510(k) Applications for this Contact
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	10/26/2005
Decision Date	02/03/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review