FDA 510(k) Application Details - K073021

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K073021
Device Name	System, Tomography, Computed, Emission
Applicant	EAGLE HEART IMAGING, LLC 8407 BRYANT ST. WESTMINSTER, CO 80031-3809 US Other 510(k) Applications for this Company
Contact	JOHN KOSS Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2007
Decision Date	11/06/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review