510(k) K083578

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

K083578 is an FDA 510(k) premarket notification submitted by Noras Mri Products GmbH for the device "NORAS CPC MULTIFUNCTIONAL COIL". The FDA issued a decision of Substantially Equivalent on January 16, 2009. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Noras Mri Products GmbH has at least 9 other 510(k) clearances on record.

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