Cleared Traditional

K190735 - EQ Balance (FDA 510(k) Clearance)

K190735 · Upright Science, Inc. · Ear, Nose, Throat device
Aug 2019
Decision
148d
Days
-
Risk

K190735 is an FDA 510(k) clearance for the EQ Balance. This device is classified as a Apparatus, Vestibular Analysis.

Submitted by Upright Science, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on August 16, 2019, 148 days after receiving the submission on March 21, 2019.

This device falls under the Ear, Nose, Throat FDA review panel.

Submission Details

510(k) Number K190735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2019
Decision Date August 16, 2019
Days to Decision 148 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LXV - Apparatus, Vestibular Analysis
Device Class -