Cleared Traditional

GSI Novus

K172403 · Grason-Stadler, Inc. · Ear, Nose, Throat
Oct 2017
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K172403 is an FDA 510(k) clearance for the GSI Novus, a Audiometer (Class II — Special Controls, product code EWO), submitted by Grason-Stadler, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on October 20, 2017, 72 days after receiving the submission on August 9, 2017. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K172403 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2017
Decision Date October 20, 2017
Days to Decision 72 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EWO — Audiometer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1050