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FDA 510(k)

ELECTRONYSTAGMOGRAPH (ENG RECORDER)

K-Number: K850180 · 1985-07-22

ApplicantBio-Logic Systems Corp.
Decision Date1985-07-22
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTRONYSTAGMOGRAPH (ENG RECORDER) is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Logic Systems Corp.. It received FDA 510(k) clearance on 1985-07-22 under 510(k) number K850180. 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 ELECTRONYSTAGMOGRAPH (ENG RECORDER)?

ELECTRONYSTAGMOGRAPH (ENG RECORDER) is a medical device that received FDA 510(k) clearance on 1985-07-22. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K850180.

When did ELECTRONYSTAGMOGRAPH (ENG RECORDER) receive FDA 510(k) clearance?

ELECTRONYSTAGMOGRAPH (ENG RECORDER) received FDA 510(k) clearance on 1985-07-22, under 510(k) number K850180.

Who is the listed applicant for ELECTRONYSTAGMOGRAPH (ENG RECORDER)?

The FDA 510(k) record lists Bio-Logic Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRONYSTAGMOGRAPH (ENG RECORDER)?

The FDA product code for ELECTRONYSTAGMOGRAPH (ENG RECORDER) is GWN.

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Other records listing Bio-Logic Systems Corp. as applicant

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Related Devices (Code: 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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