FDA 510(k) Application Details - K030145

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K030145
Device Name	Computer, Diagnostic, Programmable
Applicant	GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 MIAMI BEACH, FL 33140 US Other 510(k) Applications for this Company
Contact	EDUARDO REY 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	01/15/2003
Decision Date	09/17/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review