EEG Electrodes Model 445 Series

FDA 510(k) K982053 · Class A Ent.

Substantially Equivalent

510(k) numberK982053

Submission

Device name
EEG Electrodes Model 445 Series
Applicant
Class A Ent.
Yucca Valley, CA, US
Received
June 11, 1998
Decision date
April 20, 1999
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 Model 445 Series cleared by the FDA?

EEG Electrodes Model 445 Series (K982053) received a 510(k) decision of Substantially Equivalent on April 20, 1999, 313 days after the submission was received.

What is the product code of K982053?

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