FDA 510(k) Application Details - K201117

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K201117
Device Name	Accelerator, Linear, Medical
Applicant	Naslund Medical AB Avagen 40 B Huddinge 14130 SE Other 510(k) Applications for this Company
Contact	Tomas Naslund 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	04/27/2020
Decision Date	06/11/2020
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