NemoFAB
System, Image Processing, Radiological
Software Nemotec S.L.
The following data is part of a premarket notification filed by Software Nemotec S.l. with the FDA for Nemofab.
Pre-market Notification Details
| Device ID | K192475 |
| 510k Number | K192475 |
| Device Name: | NemoFAB |
| Classification | System, Image Processing, Radiological |
| Applicant | Software Nemotec S.L. Juan De La Cierva Street, 66 Arroyomolinos, Madrid, ES 28939 |
| Contact | Carlos Arias |
| Correspondent | Kevin Walls Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-10 |
| Decision Date | 2020-04-23 |
Trademark Results [NemoFAB]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEMOFAB 88025068 5695767 Live/Registered |
Arnett Facial Reconstruction Courses, Inc. 2018-07-03 |
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