510(k) K083578

NORAS CPC MULTIFUNCTIONAL COIL by Noras Mri Products GmbH — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2009
Date Received
December 3, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type