The following data is part of a premarket notification filed by Medovent Gmbh with the FDA for Reaxon Plus.
| Device ID | K180222 |
| 510k Number | K180222 |
| Device Name: | Reaxon Plus |
| Classification | Cuff, Nerve |
| Applicant | Medovent GmbH Friedrich-Koenig-Str. 3 Mainz, DE 55129 |
| Contact | Peter Meier |
| Correspondent | Peter Meier Medovent GmbH Friedrich-Koenig-Str. 3 Mainz, DE 55129 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-25 |
| Decision Date | 2018-04-24 |
| Summary: | summary |