The following data is part of a premarket notification filed by Quadrant Biosciences with the FDA for Clearedge Balance System.
| Device ID | K183661 |
| 510k Number | K183661 |
| Device Name: | ClearEdge Balance System |
| Classification | Apparatus, Vestibular Analysis |
| Applicant | Quadrant Biosciences 505 Irving Avenue Syracuse, NY 13210 |
| Contact | Bryan Greene |
| Correspondent | Bryan Greene Quadrant Biosciences 505 Irving Avenue Syracuse, NY 13210 |
| Product Code | LXV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-27 |
| Decision Date | 2019-10-22 |
| Summary: | summary |