The following data is part of a premarket notification filed by Oehm Und Rehbein Gmbh with the FDA for Dicompacs Dx-r With Flat Panel.
| Device ID | K131211 |
| 510k Number | K131211 |
| Device Name: | DICOMPACS DX-R WITH FLAT PANEL |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | OEHM UND REHBEIN GMBH NEPTUNALLEE 7C Rockstock, DE 18057 |
| Contact | Franziska Guenther |
| Correspondent | Franziska Guenther OEHM UND REHBEIN GMBH NEPTUNALLEE 7C Rockstock, DE 18057 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-29 |
| Decision Date | 2013-11-05 |
| Summary: | summary |