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FDA 510(k)

CONDUCTIVE EEG ELECTROLYTE

K-Number: K033052 · 2003-12-17

ApplicantCompumedics USA, Ltd.
Decision Date2003-12-17
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CONDUCTIVE EEG ELECTROLYTE is the device name listed in this FDA 510(k) record. The listed applicant is Compumedics USA, Ltd.. It received FDA 510(k) clearance on 2003-12-17 under 510(k) number K033052. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONDUCTIVE EEG ELECTROLYTE?

CONDUCTIVE EEG ELECTROLYTE is a medical device that received FDA 510(k) clearance on 2003-12-17. The listed applicant is Compumedics USA, Ltd.. The 510(k) number is K033052.

When did CONDUCTIVE EEG ELECTROLYTE receive FDA 510(k) clearance?

CONDUCTIVE EEG ELECTROLYTE received FDA 510(k) clearance on 2003-12-17, under 510(k) number K033052.

Who is the listed applicant for CONDUCTIVE EEG ELECTROLYTE?

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

What is the FDA product code for CONDUCTIVE EEG ELECTROLYTE?

The FDA product code for CONDUCTIVE EEG ELECTROLYTE is GYB.

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Other records listing Compumedics USA, Ltd. 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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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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