FDA 510(k) Application Details - K211983

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K211983
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	AMRA Medical AB Badhusgatan 5 Linkoping 582 22 SE Other 510(k) Applications for this Company
Contact	Eric Converse Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	LNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2021
Decision Date	11/24/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review