FDA 510(k) Application Details - K161631

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K161631
Device Name	System, Tomography, Computed, Emission
Applicant	GENERAL EQUIPMENT FOR MEDICAL IMAGING EDUARDO PRIMO YUFERA, N 3 VALENCIA 46012 ES Other 510(k) Applications for this Company
Contact	JOSE MONTES 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	06/13/2016
Decision Date	07/28/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review