Sys. for Rec. Bser Responses

Q: What is the product code of K770268?

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) K770268 · Life-Tech Instruments, Inc.

Substantially Equivalent

510(k) numberK770268

Submission

Device name: Sys. for Rec. Bser Responses
Applicant: Life-Tech Instruments, Inc.
Mchenry, IL, US
Received: February 11, 1977
Decision date: February 28, 1977
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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
K812177	Life-Tech #1857 Pressure/Polot ModuleEXQ · Traditional	09/09/1981SE
K812179	Life-Tech #1753 Biofeedback TrainerHCC · Traditional	08/25/1981SE
K812180	Life-Tech #5102 VisulabGWN · Traditional	08/21/1981SE
K812178	Life-Tech #'S 1106/1156 UrolabsFAP · Traditional	08/13/1981SE
K800112	Amblyopia TrainerHPL · Traditional	03/10/1980SE
K790663	Model 1750 Standing UrinalFFG · Traditional	04/24/1979SE
K790664	Model 1309 Audio MonitorIKN · Traditional	04/23/1979SE
K781476	Mular Gold Leaf Electrode Model 7501HLZ · Traditional	11/15/1978SE
K781461	Model 7320 Visual StimulatorGWE · Traditional	11/08/1978SE
K781475	Electrode Impedance Tester-Model 500GYA · Traditional	09/07/1978SE

Questions and answers

When was Sys. for Rec. Bser Responses cleared by the FDA?

Sys. for Rec. Bser Responses (K770268) received a 510(k) decision of Substantially Equivalent on February 28, 1977, 17 days after the submission was received.

What is the product code of K770268?

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