510(k) K132444

ATAMA SYSTEM by Monteris Medical, — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2014
Date Received
August 6, 2013
Clearance Type
Traditional
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