FDA 510(k) Application Details - K180123

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K180123
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	Noras MRI products GmbH Leibnizstrasse 4 Hoechberg 97204 DE Other 510(k) Applications for this Company
Contact	Jens Heidenmann Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	MOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2018
Decision Date	02/16/2018
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