EXOMIO, MODEL 2.0 SP1

System, Simulation, Radiation Therapy

MEDCOM GMBH

The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Exomio, Model 2.0 Sp1.

Pre-market Notification Details

Device IDK032550
510k NumberK032550
Device Name:EXOMIO, MODEL 2.0 SP1
ClassificationSystem, Simulation, Radiation Therapy
Applicant MEDCOM GMBH RUNDETURMSTR. 12 Darmstadt, Hessen,  DE 64283
ContactStefan Walter
CorrespondentStefan Walter
MEDCOM GMBH RUNDETURMSTR. 12 Darmstadt, Hessen,  DE 64283
Product CodeKPQ  
CFR Regulation Number892.5840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-18
Decision Date2003-09-25
Summary:summary

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