FDA 510(k) Application Details - K960338

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K960338
Device Name	Accelerator, Linear, Medical
Applicant	ELEKTA INSTRUMENT AB 181 40 SMOKESIGNAL DR. SAN DIEGO, CA 92127 US Other 510(k) Applications for this Company
Contact	CAROL PATTERSON 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	01/24/1996
Decision Date	04/23/1996
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