The following data is part of a premarket notification filed by Eizo Gmbh with the FDA for Radiforce Large Monitor System.
| Device ID | K112645 |
| 510k Number | K112645 |
| Device Name: | RADIFORCE LARGE MONITOR SYSTEM |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | EIZO GMBH SIEMENSALLEE 84 D-76187 Karlsrube, DE |
| Contact | Bernd Homberg |
| Correspondent | Bhavesh V Sheth INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-09-12 |
| Decision Date | 2011-09-22 |
| Summary: | summary |