Dermtrode

FDA 510(k) K883869 · World Precision Instruments, Inc.

Substantially Equivalent

510(k) numberK883869

Submission

Device name
Dermtrode
Applicant
World Precision Instruments, Inc.
New Haven, CT, US
Received
September 13, 1988
Decision date
September 30, 1988
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

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K854396Rub E-ZGYA · Traditional E-Z Instruments Co.05/08/1986SE
K830877Ap-CheckGYA · Traditional General Devices06/08/1983SE
K820040Sc-It Impedance TesterGYA · Traditional Cadwell Laboratories, Inc.01/28/1982SE
K781475Electrode Impedance Tester-Model 500GYA · Traditional Life-Tech Instruments, Inc.09/07/1978SE

More from Life-Tech Instruments, Inc.

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K852289Model SA3 Esophageal PH ElectrodeFFT · Traditional 07/25/1985SE

Questions and answers

When was Dermtrode cleared by the FDA?

Dermtrode (K883869) received a 510(k) decision of Substantially Equivalent on September 30, 1988, 17 days after the submission was received.

What is the product code of K883869?

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