FDA 510(k)

ELECTROENCEPHALOGRAPH RECORDING SYSTEM

K-Number: K920127 · 1992-06-10

Decision Date1992-06-10

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ELECTROENCEPHALOGRAPH RECORDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medelec Intl. Corp.. It received FDA 510(k) clearance on 1992-06-10 under 510(k) number K920127. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROENCEPHALOGRAPH RECORDING SYSTEM?

ELECTROENCEPHALOGRAPH RECORDING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-06-10. The listed applicant is Medelec Intl. Corp.. The 510(k) number is K920127.

When did ELECTROENCEPHALOGRAPH RECORDING SYSTEM receive FDA 510(k) clearance?

ELECTROENCEPHALOGRAPH RECORDING SYSTEM received FDA 510(k) clearance on 1992-06-10, under 510(k) number K920127.

Who is the listed applicant for ELECTROENCEPHALOGRAPH RECORDING SYSTEM?

The FDA 510(k) record lists Medelec Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROENCEPHALOGRAPH RECORDING SYSTEM?

The FDA product code for ELECTROENCEPHALOGRAPH RECORDING SYSTEM is GWQ.

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Related Devices (Code: GWQ)

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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.