The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Exomio, Model 2.0 Sp1.
| Device ID | K032550 |
| 510k Number | K032550 |
| Device Name: | EXOMIO, MODEL 2.0 SP1 |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | MEDCOM GMBH RUNDETURMSTR. 12 Darmstadt, Hessen, DE 64283 |
| Contact | Stefan Walter |
| Correspondent | Stefan Walter MEDCOM GMBH RUNDETURMSTR. 12 Darmstadt, Hessen, DE 64283 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-18 |
| Decision Date | 2003-09-25 |
| Summary: | summary |