Type 1077 Accuscreen

Q: What is the product code of K122067?

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) K122067 · Gn Otometrics

Substantially Equivalent

510(k) numberK122067

Submission

Device name: Type 1077 Accuscreen
Applicant: Gn Otometrics
Taastrup, DK
Received: July 16, 2012
Decision date: September 27, 2012
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

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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K242954	Integrity V500 (Integrity, Integrity with VEMP)GWJ · Traditional	Vivosonic, Inc.	12/19/2024SE
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
K161707	Madsen ZodiacETY · Special	09/01/2016SE
K151504	ICS ImpulseGWN · Traditional	11/16/2015SE
K132957	Madsen Accuscreen Type 1077GWJ · Traditional	02/27/2014SE
K122550	Ics ImpulseGWN · Traditional	02/01/2013SE
K122028	Aurical HitETW · Traditional	10/23/2012SE
K092373	Ics Chartr Ep 200GWJ · Special	09/03/2009SE
K081234	GN Otometrics Insert EarphonesEWO · Traditional	07/14/2008SE

Questions and answers

When was Type 1077 Accuscreen cleared by the FDA?

Type 1077 Accuscreen (K122067) received a 510(k) decision of Substantially Equivalent on September 27, 2012, 73 days after the submission was received.

What is the product code of K122067?

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