FDA 510(k) Application Details - K993620

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K993620
Device Name	Computer, Diagnostic, Programmable
Applicant	DEL MAR MEDICAL SYSTEMS, LLC. 1621 ALTON PKWY. IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	NEVINE ERIAN 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	10/26/1999
Decision Date	11/12/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review