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FDA 510(k)

LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812

K-Number: K023472 · 2003-03-18

ApplicantClass A Enterprises, Inc.
Decision Date2003-03-18
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 is the device name listed in this FDA 510(k) record. The listed applicant is Class A Enterprises, Inc.. It received FDA 510(k) clearance on 2003-03-18 under 510(k) number K023472. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812?

LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 is a medical device that received FDA 510(k) clearance on 2003-03-18. The listed applicant is Class A Enterprises, Inc.. The 510(k) number is K023472.

When did LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 receive FDA 510(k) clearance?

LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 received FDA 510(k) clearance on 2003-03-18, under 510(k) number K023472.

Who is the listed applicant for LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812?

The FDA 510(k) record lists Class A Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812?

The FDA product code for LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 is GXZ.

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Related Devices (Code: GXZ)

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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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