FDA 510(k) Application Details - K222112

Device Classification Name	More FDA Info for this Device
510(K) Number	K222112
Device Name	Comfort Marker 2.0
Applicant	Medical Precision BV Telfordstraat 9-30 Zwolle NL 8013 RL NL Other 510(k) Applications for this Company
Contact	Blerta Kukaj 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	07/18/2022
Decision Date	03/30/2023
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