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FDA 510(k)

MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM

K-Number: K872725 · 1987-08-14

ApplicantEyetronics, Inc.
Decision Date1987-08-14
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Eyetronics, Inc.. It received FDA 510(k) clearance on 1987-08-14 under 510(k) number K872725. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM?

MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM is a medical device that received FDA 510(k) clearance on 1987-08-14. The listed applicant is Eyetronics, Inc.. The 510(k) number is K872725.

When did MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM receive FDA 510(k) clearance?

MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM received FDA 510(k) clearance on 1987-08-14, under 510(k) number K872725.

Who is the listed applicant for MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM?

The FDA 510(k) record lists Eyetronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM?

The FDA product code for MODEL 100 VISUAL EVOKED RESPONSE RECORDING SYSTEM is GWE.

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Related Devices (Code: GWE)

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

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

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