FDA 510(k) Application Details - K212239

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K212239
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	Polarean, Inc. PO Box 14805 Research Triangle Park, NC 27709-4805 US Other 510(k) Applications for this Company
Contact	Neil Wadehra 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	07/19/2021
Decision Date	12/23/2022
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