FDA 510(k) Application Details - K083384

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K083384
Device Name	Catheter, Intravascular, Diagnostic
Applicant	BIOSENSORS INTL. PTE. LTD. 21 KALLANG AVENUE #07-167 SINGAPORE 339412 SG Other 510(k) Applications for this Company
Contact	MOSES THAM Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2008
Decision Date	01/05/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review