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 |