The following data is part of a premarket notification filed by Software Nemotec S.l. with the FDA for Nemocast.
| Device ID | K193003 |
| 510k Number | K193003 |
| Device Name: | NemoCast |
| Classification | Orthodontic Software |
| 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 | PNN |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-28 |
| Decision Date | 2020-06-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NEMOCAST 79366270 not registered Live/Pending |
SOFTWARE NEMOTEC S.L. 2023-01-17 |