Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit— 510(k) K143395

Name: FDA 510(k) clearance K143395
Creator: U.S. Food and Drug Administration
Published: 2015-02-23

Substantially Equivalent

Otodynamics, Ltd.

FDA 510(k) clearance K143395 for Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit, Substantially Equivalent on 2015-02-23. Applicant: Otodynamics, Ltd.. Device class: 2.

Clearance details

Applicant: Otodynamics, Ltd.
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 2014-11-26
Decision date: 2015-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatfield, Herts, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Otodynamics, Ltd.

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K072033 — OTODYNAMICS OTOPORT2007-11-13
K983350 — ILO292 DP ECHOPORT PLUS OAE SYSTEM1998-12-11
K983351 — ILO292 DP ECHOPORT PLUS OAE SYSTEM1998-12-11
K983352 — ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK1998-12-11
K962995 — ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC1997-01-10

Adverse events under product code EWO

product code EWO

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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