510(k) K121530

BODYFIX SYSTEM by Medical Intelligence Medizintechnik GmbH — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2012
Date Received
May 24, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type