FDA 510(k) Application Details - K211590

Device Classification Name	Accelerator, Linear, Medical   More FDA Info for this Device
510(K) Number	K211590
Device Name	Accelerator, Linear, Medical
Applicant	Carbon Medical Technologies Inc. 1290 Hammond Road St. Paul, MN 55110 US Other 510(k) Applications for this Company
Contact	Eric Furlich 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	05/24/2021
Decision Date	06/10/2021
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