The following data is part of a premarket notification filed by Oehm Und Rehbein Gmbh with the FDA for Amadeo M-dr Mini, Amadeo M-ax Mini.
| Device ID | K182317 |
| 510k Number | K182317 |
| Device Name: | AMADEO M-DR Mini, AMADEO M-AX Mini |
| Classification | System, X-ray, Mobile |
| Applicant | OEHM UND REHBEIN GMBH Neptunallee 7 C Rostock, DE 18057 |
| Contact | Markus Brueggmann |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-27 |
| Decision Date | 2018-09-24 |
| Summary: | summary |