The following data is part of a premarket notification filed by Brius Technologies Inc with the FDA for Brius Planner Software.
Device ID | K212828 |
510k Number | K212828 |
Device Name: | BRIUS Planner Software |
Classification | Orthodontic Software |
Applicant | BRIUS Technologies Inc 2611 Westgrove Dr Carrollton, TX 75006 |
Contact | Mehdi Roein-peiker |
Correspondent | Breanne Butler Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, TX 77043 |
Product Code | PNN |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-03 |
Decision Date | 2021-10-01 |