The following data is part of a premarket notification filed by Mindmaze Sa with the FDA for Mindmotion(tm) Go.
Device ID | K173931 |
510k Number | K173931 |
Device Name: | MindMotion(TM) GO |
Classification | System, Optical Position/movement Recording |
Applicant | MindMaze SA Chemin De Roseneck 5 Lausanne, CH Ch-1006 |
Contact | Sylvian Bourriquet |
Correspondent | Sylvian Bourriquet MindMaze SA Chemin De Roseneck 5 Lausanne, CH Ch-1006 |
Product Code | LXJ |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-26 |
Decision Date | 2018-05-17 |