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510(k) K081118

NORAS MR-BI320-PA 1.5T by Noras Mri Products GmbH — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2008
Date Received
April 21, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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