Madsen Zodiac— 510(k) K161707

Substantially Equivalent

Gn Otometrics

FDA 510(k) clearance K161707 for Madsen Zodiac, Substantially Equivalent on 2016-09-01. Applicant: Gn Otometrics. Device class: 2.

Clearance details

Applicant: Gn Otometrics
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 2016-06-21
Decision date: 2016-09-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Taastrup, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code ETY

K183201 — Hearing Healthcare Pro2019-03-06
K171038 — Hearing Healthcare Pro2017-08-02
K162210 — touchTymp2016-11-16
K151616 — AT2352015-07-15
K151509 — GSI TympStar Pro Middle Ear Analyzer2015-06-25

More clearances from Gn Otometrics

K151504 — ICS Impulse2015-11-16
K132957 — MADSEN ACCUSCREEN TYPE 10772014-02-27
K122550 — ICS IMPULSE2013-02-01
K122028 — AURICAL HIT2012-10-23
K122067 — TYPE 1077 ACCUSCREEN2012-09-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.