Cleared Traditional

K183661 - ClearEdge Balance System (FDA 510(k) Clearance)

K183661 · Quadrant Biosciences · Ear, Nose, Throat device
Oct 2019
Decision
299d
Days
-
Risk

K183661 is an FDA 510(k) clearance for the ClearEdge Balance System. This device is classified as 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 FDA review panel.

Submission Details

510(k) Number K183661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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

Device Classification

Product Code LXV - Apparatus, Vestibular Analysis
Device Class -