FDA 510(k) Application Details - K002051

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K002051
Device Name	Accelerator, Linear, Medical
Applicant	SCANDITRONIX MEDICAL AB STALGATAN 14 UPPSALA S-754 50 S-754 50 SE Other 510(k) Applications for this Company
Contact	EVA LARSTEN Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	IYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2000
Decision Date	09/05/2000
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	N
Expedited Review