FDA 510(k) Application Details - K073113

Device Classification Name	Computer, Diagnostic, Pre-Programmed, Single-Function   More FDA Info for this Device
510(K) Number	K073113
Device Name	Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant	Draeger Medical Systems, Inc. 6 TECH DRIVE ANDOVER, MA 01810 US Other 510(k) Applications for this Company
Contact	GENCI OMARI 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	11/05/2007
Decision Date	01/03/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review