The following data is part of a premarket notification filed by Ebm Technologies Usa, Llc with the FDA for Ebm Ido Viewer.
| Device ID | K140399 |
| 510k Number | K140399 |
| Device Name: | EBM IDO VIEWER |
| Classification | System, Image Processing, Radiological |
| Applicant | EBM TECHNOLOGIES USA, LLC 641 Keeaumoku St Ste 5 Honolulu, HI 96814 |
| Contact | John Su |
| Correspondent | John Su EBM TECHNOLOGIES USA, LLC 641 Keeaumoku St Ste 5 Honolulu, HI 96814 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-18 |
| Decision Date | 2014-09-18 |