Electrode Impedance Tester-Model 500

Q: What is the product code of K781475?

The FDA product code is GYA – Tester, Electrode/Lead, Electroencephalograph, a Class I (low risk) device regulated under 21 CFR 882.1410.

FDA 510(k) K781475 · Life-Tech Instruments, Inc.

Substantially Equivalent

510(k) numberK781475

Submission

Device name: Electrode Impedance Tester-Model 500
Applicant: Life-Tech Instruments, Inc.
Mchenry, IL, US
Received: August 28, 1978
Decision date: September 7, 1978
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: GYA – Tester, Electrode/Lead, Electroencephalograph
Device class: Class I (low risk)
Regulation: 21 CFR 882.1410
Specialty: Neurology

Other 510(k)s with product code GYA

510(k)	Device	Applicant	Decision
K883869	DermtrodeGYA · Traditional	World Precision Instruments, Inc.	09/30/1988SE
K854396	Rub E-ZGYA · Traditional	E-Z Instruments Co.	05/08/1986SE
K830877	Ap-CheckGYA · Traditional	General Devices	06/08/1983SE
K820040	Sc-It Impedance TesterGYA · Traditional	Cadwell Laboratories, Inc.	01/28/1982SE

More from Cadwell Laboratories, Inc.

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
K781474	Preamplifier Models 8101PI & 8102PIEWO · Traditional	09/07/1978SE

Questions and answers

When was Electrode Impedance Tester-Model 500 cleared by the FDA?

Electrode Impedance Tester-Model 500 (K781475) received a 510(k) decision of Substantially Equivalent on September 7, 1978, 10 days after the submission was received.

What is the product code of K781475?

The FDA product code is GYA – Tester, Electrode/Lead, Electroencephalograph, a Class I (low risk) device regulated under 21 CFR 882.1410.