FDA 510(k) Application Details - K072735

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K072735
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	PULSION MEDICAL SYSTEMS AG 7220 SPARHAWK RD. WAKE FOREST, NC 27587 US Other 510(k) Applications for this Company
Contact	Jamie Sulley Other 510(k) Applications for this Contact
Regulation Number	870.1435   More FDA Info for this Regulation Number
Classification Product Code	DXG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2007
Decision Date	10/18/2007
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