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FDA 510(k)

EVOKED RESPONSE ELECTRICAL STIMULATOR

K-Number: K843226 · 1985-05-21

ApplicantNucleus, Ltd.
Decision Date1985-05-21
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EVOKED RESPONSE ELECTRICAL STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Nucleus, Ltd.. It received FDA 510(k) clearance on 1985-05-21 under 510(k) number K843226. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOKED RESPONSE ELECTRICAL STIMULATOR?

EVOKED RESPONSE ELECTRICAL STIMULATOR is a medical device that received FDA 510(k) clearance on 1985-05-21. The listed applicant is Nucleus, Ltd.. The 510(k) number is K843226.

When did EVOKED RESPONSE ELECTRICAL STIMULATOR receive FDA 510(k) clearance?

EVOKED RESPONSE ELECTRICAL STIMULATOR received FDA 510(k) clearance on 1985-05-21, under 510(k) number K843226.

Who is the listed applicant for EVOKED RESPONSE ELECTRICAL STIMULATOR?

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

What is the FDA product code for EVOKED RESPONSE ELECTRICAL STIMULATOR?

The FDA product code for EVOKED RESPONSE ELECTRICAL STIMULATOR is ETN.

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Related Devices (Code: ETN)

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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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