Interacoustics Ep 15 Abr Stand Alone Unit

Q: What is the product code of K991853?

The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.

FDA 510(k) K991853 · Idem (Int'L Dist. of Electronics For Medicine)

Substantially Equivalent

510(k) numberK991853

Submission

Device name: Interacoustics Ep 15 Abr Stand Alone Unit
Applicant: Idem (Int'L Dist. of Electronics For Medicine)
Benicia, CA, US
Received: June 1, 1999
Decision date: October 25, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GWJ – Stimulator, Auditory, Evoked Response
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1900
Specialty: Neurology

Other 510(k)s with product code GWJ

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K233649	ALGO Pro Newborn Hearing Screener (ALGO Pro)GWJ · Traditional	Natus Medical Incorporated Dba Excel-Tech Ltd.…	03/08/2024SE
K220139	QScreenGWJ · Traditional	Path Medical GmbH	08/03/2022SE
K211147	ALGO 7iGWJ · Traditional	Path Medical GmbH	10/14/2021SE
K193033	GSI Audera ProGWJ · Traditional	Grason Stadler	04/24/2020SE
K163326	SmartEPGWJ · Traditional	Intelligent Hearing Systems	09/29/2017SE
K162037	Eclipse with VEMPGWJ · Traditional	Interacoustics A/S	03/23/2017SE
K143670	Ics Chartr Ep 200 with VempGWJ · Traditional	Gn Otometrics A/S	10/23/2015SE
K141446	Echo-Screen III Pro Hearing Screener with Barcode Scanner, Echo-Screen III Pro Hearing…GWJ · Special	Natus Medical Incorporated	08/22/2014SE
K132957	Madsen Accuscreen Type 1077GWJ · Traditional	Gn Otometrics	02/27/2014SE

More from Gn Otometrics

510(k)	Device	Decision
K990652	Interacoustics Model AZ26 Clinical Impedance AudiometerETY · Traditional	05/17/1999SE
K990585	Interacoustics AT22T Automatic Impedance AudiometerETY · Traditional	05/17/1999SE
K983832	Interacoustics Model MT 10, Handheld Impedance AudiometerETY · Traditional	01/25/1999SE
K982249	Interacoustics Model AD229 Diagnostic AudiometerEWO · Traditional	08/07/1998SE
K981327	Interacoustics Model AD226 Diagnostic AudiometerEWO · Traditional	05/11/1998SE

Questions and answers

When was Interacoustics Ep 15 Abr Stand Alone Unit cleared by the FDA?

Interacoustics Ep 15 Abr Stand Alone Unit (K991853) received a 510(k) decision of Substantially Equivalent on October 25, 1999, 146 days after the submission was received.

What is the product code of K991853?

The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.