EEG Electrodes

FDA 510(k) K962283 · Teca, Inc.

Substantially Equivalent

510(k) numberK962283

Submission

Device name
EEG Electrodes
Applicant
Teca, Inc.
Pleasantiville, NY, US
Received
June 13, 1996
Decision date
December 16, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GXY – Electrode, Cutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1320
Specialty
Neurology

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Questions and answers

When was EEG Electrodes cleared by the FDA?

EEG Electrodes (K962283) received a 510(k) decision of Substantially Equivalent on December 16, 1996, 186 days after the submission was received.

What is the product code of K962283?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.