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510(k) K153014

Mobius3D by Mobius Medical Systems, LP — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2016
Date Received
October 15, 2015
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

Other clearances by Mobius Medical Systems, LP

  • K141230 — DOSELAB PRO (August 27, 2014)
  • K140660 — MOBIUS3D (June 24, 2014)

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