The following data is part of a premarket notification filed by Mobius Medical Systems, Lp with the FDA for Mobius3d.
| Device ID | K153014 |
| 510k Number | K153014 |
| Device Name: | Mobius3D |
| Classification | Accelerator, Linear, Medical |
| Applicant | MOBIUS MEDICAL SYSTEMS, LP 5012 Tamarisk St Bellaire, TX 77401 |
| Contact | Stan Eshelman |
| Correspondent | Stan Eshelman MOBIUS MEDICAL SYSTEMS, LP 5012 Tamarisk St Bellaire, TX 77401 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-15 |
| Decision Date | 2016-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00899475002431 | K153014 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MOBIUS3D 86175648 5188939 Live/Registered |
Mobius Medical Systems, LP 2014-01-27 |
![]() MOBIUS3D 76533741 not registered Dead/Abandoned |
Oregon3D, Inc. 2003-07-21 |