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FDA 510(k)

EVOKED 3500 POTENTIAL SYSTEM

K-Number: K832084 · 1983-08-16

ApplicantTracor Northern, Inc.
Decision Date1983-08-16
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EVOKED 3500 POTENTIAL 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 1983-08-16 under 510(k) number K832084. 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 EVOKED 3500 POTENTIAL SYSTEM?

EVOKED 3500 POTENTIAL SYSTEM is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Tracor Northern, Inc.. The 510(k) number is K832084.

When did EVOKED 3500 POTENTIAL SYSTEM receive FDA 510(k) clearance?

EVOKED 3500 POTENTIAL SYSTEM received FDA 510(k) clearance on 1983-08-16, under 510(k) number K832084.

Who is the listed applicant for EVOKED 3500 POTENTIAL 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 EVOKED 3500 POTENTIAL SYSTEM?

The FDA product code for EVOKED 3500 POTENTIAL SYSTEM is GWE.

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Other records listing Tracor Northern, Inc. as applicant

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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Related Devices (Code: GWE)

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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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