Emg Surface, Digital Ring, Bar, Grounding, EEG

FDA 510(k) K850108 · Nicolet Biomedical Instruments

Substantially Equivalent

510(k) numberK850108

Submission

Device name
Emg Surface, Digital Ring, Bar, Grounding, EEG
Applicant
Nicolet Biomedical Instruments
Madison, WI, US
Received
January 10, 1985
Decision date
April 11, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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K851190Nystagmograph Eog/Eng AnalysesGWN · Traditional 11/27/1985SE
K850259Electroencephalograph EEGGWQ · Traditional 04/11/1985SE
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Questions and answers

When was Emg Surface, Digital Ring, Bar, Grounding, EEG cleared by the FDA?

Emg Surface, Digital Ring, Bar, Grounding, EEG (K850108) received a 510(k) decision of Substantially Equivalent on April 11, 1985, 91 days after the submission was received.

What is the product code of K850108?

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