The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Pvs Model 1.0.
| Device ID | K102237 |
| 510k Number | K102237 |
| Device Name: | PVS MODEL 1.0 |
| 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 | 2010-08-09 |
| Decision Date | 2010-11-23 |