The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Exomio, Model 1.1.
| Device ID | K022219 |
| 510k Number | K022219 |
| Device Name: | EXOMIO, MODEL 1.1 |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | MEDCOM GMBH RUNDETURMSTR. 12 Darmstadt, Hessen, DE 64283 |
| Contact | Ioannis Nomikos |
| Correspondent | Ioannis Nomikos MEDCOM GMBH RUNDETURMSTR. 12 Darmstadt, Hessen, DE 64283 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-09 |
| Decision Date | 2002-10-07 |
| Summary: | summary |