Cleared Traditional

GSI Corti

K180287 · Grason-Stadler, Inc. · Ear, Nose, Throat
May 2018
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K180287 is an FDA 510(k) clearance for the GSI Corti, a Audiometer (Class II — Special Controls, product code EWO), submitted by Grason-Stadler, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 11, 2018, 99 days after receiving the submission on February 1, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K180287 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2018
Decision Date May 11, 2018
Days to Decision 99 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