510(k) K022219

EXOMIO, MODEL 1.1 by Medcom GmbH — Product Code KPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2002
Date Received
July 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Simulation, Radiation Therapy
Device Class
Class II
Regulation Number
892.5840
Review Panel
RA
Submission Type