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FDA 510(k)

NYSTAGMOGRAPH EOG/ENG ANALYSES

K-Number: K851190 · 1985-11-27

ApplicantNicolet Biomedical Instruments
Decision Date1985-11-27
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NYSTAGMOGRAPH EOG/ENG ANALYSES 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 1985-11-27 under 510(k) number K851190. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NYSTAGMOGRAPH EOG/ENG ANALYSES?

NYSTAGMOGRAPH EOG/ENG ANALYSES is a medical device that received FDA 510(k) clearance on 1985-11-27. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K851190.

When did NYSTAGMOGRAPH EOG/ENG ANALYSES receive FDA 510(k) clearance?

NYSTAGMOGRAPH EOG/ENG ANALYSES received FDA 510(k) clearance on 1985-11-27, under 510(k) number K851190.

Who is the listed applicant for NYSTAGMOGRAPH EOG/ENG ANALYSES?

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 NYSTAGMOGRAPH EOG/ENG ANALYSES?

The FDA product code for NYSTAGMOGRAPH EOG/ENG ANALYSES is GWN.

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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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