FDA 510(k) Application Details - K080704

Device Classification Name	Monitor, Electric For Gravity Flow Infusion Systems   More FDA Info for this Device
510(K) Number	K080704
Device Name	Monitor, Electric For Gravity Flow Infusion Systems
Applicant	EM-TEC GMBH LERCHENBERG 20 FINNING, BAVARIA 86923 DE Other 510(k) Applications for this Company
Contact	BERNHARD BRAND Other 510(k) Applications for this Contact
Regulation Number	880.2420   More FDA Info for this Regulation Number
Classification Product Code	FLN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2008
Decision Date	04/17/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review