The following data is part of a premarket notification filed by 3d Line Usa, Inc. with the FDA for Dmlc Iv-ergo.
| Device ID | K001163 |
| 510k Number | K001163 |
| Device Name: | DMLC IV-ERGO |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | 3D LINE USA, INC. 2807 OLD COURT RD. Baltimore, MD 21208 |
| Contact | Karen H Rigamonti |
| Correspondent | Karen H Rigamonti 3D LINE USA, INC. 2807 OLD COURT RD. Baltimore, MD 21208 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-10-23 |