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FDA 510(k)

EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG

K-Number: K850108 · 1985-04-11

ApplicantNicolet Biomedical Instruments
Decision Date1985-04-11
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical Instruments. It received FDA 510(k) clearance on 1985-04-11 under 510(k) number K850108. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG?

EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG is a medical device that received FDA 510(k) clearance on 1985-04-11. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K850108.

When did EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG receive FDA 510(k) clearance?

EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG received FDA 510(k) clearance on 1985-04-11, under 510(k) number K850108.

Who is the listed applicant for EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG?

The FDA 510(k) record lists Nicolet Biomedical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG?

The FDA product code for EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG is GXY.

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Other records listing Nicolet Biomedical Instruments as applicant

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Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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