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 |