FDA 510(k) Application Details - DEN200041

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200041
Device Name	Comfort Marker 2.0.
Applicant	Medical Precision B.V. Telfordstraat 9 - 30 Zwolle 8013 RL NL Other 510(k) Applications for this Company
Contact	Roland Kortenhorst Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2020
Decision Date	12/10/2021
Decision	DENG -
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review