The following data is part of a premarket notification filed by Wellhofer Dosimetrie with the FDA for Omnipro I'mrt.
| Device ID | K031634 |
| 510k Number | K031634 |
| Device Name: | OMNIPRO I'MRT |
| Classification | Accelerator, Linear, Medical |
| Applicant | WELLHOFER DOSIMETRIE STALGATAN 14 Uppsala, SE 75450 |
| Contact | Thomas Matzen |
| Correspondent | Thomas Matzen WELLHOFER DOSIMETRIE STALGATAN 14 Uppsala, SE 75450 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-27 |
| Decision Date | 2003-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EIBAMQ040000 | K031634 | 000 |
| EIBAMQ002700 | K031634 | 000 |
| EIBAE30633000 | K031634 | 000 |
| EIBAE30701001 | K031634 | 000 |
| EIBAE30300151 | K031634 | 000 |
| EIBAE60200601 | K031634 | 000 |
| EIBAM98000001 | K031634 | 000 |
| EIBAMQ002000 | K031634 | 000 |
| EIBAMQ010000 | K031634 | 000 |
| EIBAMQ020000 | K031634 | 000 |
| EIBAMQ030000 | K031634 | 000 |
| EIBAE30702001 | K031634 | 000 |