The following data is part of a premarket notification filed by Scientific Analytics, Inc. with the FDA for Dari Health.
| Device ID | K180880 |
| 510k Number | K180880 |
| Device Name: | DARI Health |
| Classification | System, Optical Position/movement Recording |
| Applicant | Scientific Analytics, Inc. 2100 Magnum Circle, Suite 7 Lincoln, NE 68522 |
| Contact | Joel Hungate |
| Correspondent | Evan P. Phelps OFW Law 600 New Hampshire Ave., NW Suite 500 Washington, DC 20037 |
| Product Code | LXJ |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-03 |
| Decision Date | 2019-03-07 |