OTOFLEX 100 TYE 1012— 510(k) K033645

Substantially Equivalent

Gn Otometrics A/S

FDA 510(k) clearance K033645 for OTOFLEX 100 TYE 1012, Substantially Equivalent on 2004-03-31. Applicant: Gn Otometrics A/S. Device class: 2.

Clearance details

Applicant: Gn Otometrics A/S
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 2003-11-20
Decision date: 2004-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taastrup, DK

Download summary PDF View on FDA.gov ↗

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K061104 — SPEECHLINK 100 TYPE 10532006-05-03

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