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FDA 510(k)

EEG LEAD ASSEMBLY

K-Number: K781494 · 1978-10-31

ApplicantGraphic Controls Corp.
Decision Date1978-10-31
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EEG LEAD ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Graphic Controls Corp.. It received FDA 510(k) clearance on 1978-10-31 under 510(k) number K781494. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EEG LEAD ASSEMBLY?

EEG LEAD ASSEMBLY is a medical device that received FDA 510(k) clearance on 1978-10-31. The listed applicant is Graphic Controls Corp.. The 510(k) number is K781494.

When did EEG LEAD ASSEMBLY receive FDA 510(k) clearance?

EEG LEAD ASSEMBLY received FDA 510(k) clearance on 1978-10-31, under 510(k) number K781494.

Who is the listed applicant for EEG LEAD ASSEMBLY?

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

What is the FDA product code for EEG LEAD ASSEMBLY?

The FDA product code for EEG LEAD ASSEMBLY is GXY.

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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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