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 | K141440 |
510k Number | K141440 |
Device Name: | DICOMPACS DX-R WITH FLAT PANEL |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | OEHM UND REHBEIN GMBH 8870 RAVELLO CT Naples, FL 34114 |
Contact | Daniel Kamm, P.e. |
Correspondent | Daniel Kamm, P.e. OEHM UND REHBEIN GMBH 8870 RAVELLO CT Naples, FL 34114 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-02 |
Decision Date | 2014-08-29 |
Summary: | summary |