FDA 510(k) Application Details - K042463

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K042463
Device Name	Computer, Diagnostic, Programmable
Applicant	ROZINN ELECTRONICS, INC. 71-22 MYRTLE AVE. GLENDALE, NY 11385 US Other 510(k) Applications for this Company
Contact	MARK ROSOFF 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	09/13/2004
Decision Date	09/22/2004
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