TYPE 1077 ACCUSCREEN— 510(k) K122067

Substantially Equivalent

Gn Otometrics

FDA 510(k) clearance K122067 for TYPE 1077 ACCUSCREEN, Substantially Equivalent on 2012-09-27. Applicant: Gn Otometrics. Device class: 2.

Clearance details

Applicant: Gn Otometrics
Product code: Code GWJ
Device class: Class 2
Regulation: 21 CFR 882.1900
Advisory panel: Neurology
Date received: 2012-07-16
Decision date: 2012-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taastrup, DK

Download summary PDF View on FDA.gov ↗

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K220139 — QScreen2022-08-03
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More clearances from Gn Otometrics

K161707 — Madsen Zodiac2016-09-01
K151504 — ICS Impulse2015-11-16
K132957 — MADSEN ACCUSCREEN TYPE 10772014-02-27
K122550 — ICS IMPULSE2013-02-01
K122028 — AURICAL HIT2012-10-23

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