FDA 510(k) Application Details - K143389

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K143389
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	GE HEALTHCARE COILS (USA INSTRUMENTS INC.) 1515 DANNER DR AURORA, OH 44202-9273 US Other 510(k) Applications for this Company
Contact	Candice C Mandera 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	11/26/2014
Decision Date	03/06/2015
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