The Pilot Audiometer

FDA 510(k) K951527 · American Electromedics Corp.

Substantially Equivalent

510(k) numberK951527

Submission

Device name
The Pilot Audiometer
Applicant
American Electromedics Corp.
Amherst, NH, US
Received
April 3, 1995
Decision date
May 3, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

Other 510(k)s with product code EWO

510(k)DeviceApplicantDecision
K234095OtoNova/OtoNova ProEWO · Traditional Otodynamics06/21/2024SE
K240430Otoport ProEWO · Special Otodynamics, Ltd.03/15/2024SE
K231545hearOAEEWO · Traditional Hearx SA (Pty) , Ltd.10/27/2023SE
K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEEWO · Traditional Path Medical GmbH06/22/2022SE
K191372LyraEWO · Traditional Interacoustics A/S07/15/2019SE
K180287GSI CortiEWO · Traditional Grason-Stadler, Inc.05/11/2018SE
K173567SeraEWO · Traditional Interacoustics A/S02/14/2018SE
K172403GSI NovusEWO · Traditional Grason-Stadler, Inc.10/20/2017SE
K171506EasyscreenEWO · Traditional Maico Diagnostics GmbH08/29/2017SE
K151025iHearTestEWO · Traditional Ihear Medical, Inc.12/29/2015SE

More from Ihear Medical, Inc.

510(k)DeviceDecision
K983051American Electromedics Race Ca Tympanometer/Audiometer with Integral PrinterETY · Traditional 11/18/1998SE
K983049American Electromedics Quik Tymp 1 (QT1) Tympanometer with Intergral PrinterETY · Traditional 11/18/1998SE
K983048American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer with Integral PrinterEWO · Traditional 11/17/1998SE
K983046American Electromedics Race Car Tympanometer W/Integral PrinterETY · Traditional 11/17/1998SE
K972221K 15 AudiometerEWO · Traditional 09/08/1997SE
K970279Race Car Tympanometer with Audiometer(Ae-Rcaud I/Quik Tymp 1(AE-QUIK 1)/QUICK Tymp…EWO · Traditional 03/18/1997SE
K955289Race Car TympanometerETY · Traditional 12/08/1995SE
K930164The Automatic Impedance Meter,Model AE-208D/SETY · Traditional 04/23/1993SE
K924934Automatic Impedance Meter AE-205ETY · Traditional 01/21/1993SE
K924933AE-206 Tympnomwrwe(R) AudiometerETY · Traditional 01/21/1993SE

Questions and answers

When was The Pilot Audiometer cleared by the FDA?

The Pilot Audiometer (K951527) received a 510(k) decision of Substantially Equivalent on May 3, 1995, 30 days after the submission was received.

What is the product code of K951527?

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