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

FDA 510(k) K143395 · Otodynamics, Ltd.

Substantially Equivalent

510(k) numberK143395

Submission

Device name
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
Applicant
Otodynamics, Ltd.
Hatfield, Herts, GB
Received
November 26, 2014
Decision date
February 23, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EWO – Audiometer
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1050
Specialty
Ear, Nose, Throat

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More from Ihear Medical, Inc.

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K234095OtoNova/OtoNova ProEWO · Traditional 06/21/2024SE
K240430Otoport ProEWO · Special 03/15/2024SE
K072033Otodynamics OtoportEWO · Traditional 11/13/2007SE
K983352ILO2088 Enchocheck or ILO2088 OtocheckEWO · Traditional 12/11/1998SE
K983351ILO292 DP Echoport Plus Oae SystemEWO · Traditional 12/11/1998SE
K983350ILO292 DP Echoport Plus Oae SystemEWO · Traditional 12/11/1998SE
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Questions and answers

When was 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 cleared by the FDA?

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 (K143395) received a 510(k) decision of Substantially Equivalent on February 23, 2015, 89 days after the submission was received.

What is the product code of K143395?

The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.