FDA 510(k) Application Details - K002553

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K002553
Device Name	System, Tomography, Computed, Emission
Applicant	SMV AMERICA 8380 DARROW RD. TWINSBURG, OH 44087 US Other 510(k) Applications for this Company
Contact	LONNIE MIXON 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	08/17/2000
Decision Date	09/15/2000
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