FDA 510(k) Application Details - K033486

Device Classification Name	More FDA Info for this Device
510(K) Number	K033486
Device Name	GE PRECISION MPI
Applicant	NRT-NORDISK RONTGEN TEKNIK A/S BIRKEGAARDSVEJ 16 HASSELAGER 8361 DK Other 510(k) Applications for this Company
Contact	JAN MALLING Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2003
Decision Date	11/19/2003
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