Cleared Traditional

GSI TympStar Pro Middle Ear Analyzer

K151509 · Diagnostic Group, Dba Grason-Stadler · Ear, Nose, Throat

Jun 2015

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K151509 is an FDA 510(k) clearance for the GSI TympStar Pro Middle Ear Analyzer, a Tester, Auditory Impedance (Class II — Special Controls, product code ETY), submitted by Diagnostic Group, Dba Grason-Stadler (Eden Prairie, US). The FDA issued a Cleared decision on June 25, 2015, 21 days after receiving the submission on June 4, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.

Submission Details

510(k) Number	K151509 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2015
Decision Date	June 25, 2015
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF