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FDA 510(k)

TN-3000 EVOKED RESPONSE SYSTEM

K-Number: K810560 · 1981-03-17

ApplicantTracor Northern, Inc.
Decision Date1981-03-17
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TN-3000 EVOKED RESPONSE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tracor Northern, Inc.. It received FDA 510(k) clearance on 1981-03-17 under 510(k) number K810560. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TN-3000 EVOKED RESPONSE SYSTEM?

TN-3000 EVOKED RESPONSE SYSTEM is a medical device that received FDA 510(k) clearance on 1981-03-17. The listed applicant is Tracor Northern, Inc.. The 510(k) number is K810560.

When did TN-3000 EVOKED RESPONSE SYSTEM receive FDA 510(k) clearance?

TN-3000 EVOKED RESPONSE SYSTEM received FDA 510(k) clearance on 1981-03-17, under 510(k) number K810560.

Who is the listed applicant for TN-3000 EVOKED RESPONSE SYSTEM?

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

What is the FDA product code for TN-3000 EVOKED RESPONSE SYSTEM?

The FDA product code for TN-3000 EVOKED RESPONSE SYSTEM is GWF.

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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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