FDA 510(k) Application Details - K992388

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K992388
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	ROSSMAX INTERNATIONAL LTD. 2F. NO. 10, ALLEY 20 LANE 106 SEC 3 NON KANG RD. TAIPEI TW Other 510(k) Applications for this Company
Contact	MICHAEL YEH Other 510(k) Applications for this Contact
Regulation Number	870.2100   More FDA Info for this Regulation Number
Classification Product Code	DPW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/1999
Decision Date	08/03/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review