FDA 510(k) Application Details - K163661

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K163661
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	RAPID Biomedical GmbH Kettelerstr. 3-11 Rimpar 97222 DE Other 510(k) Applications for this Company
Contact	Christian Zimmermann 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	12/27/2016
Decision Date	03/21/2018
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