Submission Details
| 510(k) Number | K183661 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 27, 2018 |
| Decision Date | October 22, 2019 |
| Days to Decision | 299 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
ClearEdge Balance System
Oct 2019
Decision
299d
Days
—
Risk
About This 510(k) Submission
K183661 is an FDA 510(k) clearance for the ClearEdge Balance System, a Apparatus, Vestibular Analysis, submitted by Quadrant Biosciences (Syracuse, US). The FDA issued a Cleared decision on October 22, 2019, 299 days after receiving the submission on December 27, 2018. This device falls under the Ear, Nose, Throat review panel.
Device Classification
| Product Code | LXV — Apparatus, Vestibular Analysis |
| Device Class | — |
Manufacturer
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