Cleared Traditional

K-D Balance

K173669 · King-Devick Technologies, Inc. · Ear, Nose, Throat

Apr 2018

Decision

123d

Days

—

Risk

About This 510(k) Submission

K173669 is an FDA 510(k) clearance for the K-D Balance, a Apparatus, Vestibular Analysis, submitted by King-Devick Technologies, Inc. (Oakbrook Terrace, US). The FDA issued a Cleared decision on April 2, 2018, 123 days after receiving the submission on November 30, 2017. This device falls under the Ear, Nose, Throat review panel.

Submission Details

510(k) Number	K173669 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 2017
Decision Date	April 02, 2018
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF