FDA 510(k) Application Details - K992703

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K992703
Device Name	Computer, Diagnostic, Programmable
Applicant	PREMIER HEART, LLC. 601 13TH STREET, N.W. SUITE 901 SOUTH WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	WILLIAM D HARE 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	08/12/1999
Decision Date	03/21/2000
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