FDA 510(k) Application Details - K201807

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K201807
Device Name	System, Tomography, Computed, Emission
Applicant	MiEGmbH Hauptstrasse 112 Seth 23845 DE Other 510(k) Applications for this Company
Contact	Thomas Kuehl Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2020
Decision Date	08/27/2020
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