The following data is part of a premarket notification filed by 3d Line Medical Systems S.r.l. with the FDA for Ergo++ Version 1.7.
| Device ID | K080601 |
| 510k Number | K080601 |
| Device Name: | ERGO++ VERSION 1.7 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | 3D LINE MEDICAL SYSTEMS S.R.L. 4775 PEACHTREE INDUSTRIAL BLVD BLDG 300, SUITE 300 Norcross, GA 30092 |
| Contact | Thomas Valentine |
| Correspondent | Thomas Valentine 3D LINE MEDICAL SYSTEMS S.R.L. 4775 PEACHTREE INDUSTRIAL BLVD BLDG 300, SUITE 300 Norcross, GA 30092 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858164002213 | K080601 | 000 |
| 00858164002206 | K080601 | 000 |