FDA 510(k) Application Details - K051471

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K051471
Device Name	Computer, Diagnostic, Programmable
Applicant	GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG 55 Northern Blvd Suite 200 Great Neck, NY 11021 US Other 510(k) Applications for this Company
Contact	BERT SCHADOW Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2005
Decision Date	06/29/2005
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	Y
Expedited Review