The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Verisuite 1.6, Verisuite-particle 1.6.
| Device ID | K080742 |
| 510k Number | K080742 |
| Device Name: | VERISUITE 1.6, VERISUITE-PARTICLE 1.6 |
| Classification | Accelerator, Linear, Medical |
| 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 | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-17 |
| Decision Date | 2008-05-09 |
| Summary: | summary |