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FDA 510(k)

MODEL 4310 PSARRAY2 EEG ELECTRODE

K-Number: K020670 · 2002-10-08

ApplicantPhysiometrix, Inc.
Decision Date2002-10-08
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL 4310 PSARRAY2 EEG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Physiometrix, Inc.. It received FDA 510(k) clearance on 2002-10-08 under 510(k) number K020670. 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 MODEL 4310 PSARRAY2 EEG ELECTRODE?

MODEL 4310 PSARRAY2 EEG ELECTRODE is a medical device that received FDA 510(k) clearance on 2002-10-08. The listed applicant is Physiometrix, Inc.. The 510(k) number is K020670.

When did MODEL 4310 PSARRAY2 EEG ELECTRODE receive FDA 510(k) clearance?

MODEL 4310 PSARRAY2 EEG ELECTRODE received FDA 510(k) clearance on 2002-10-08, under 510(k) number K020670.

Who is the listed applicant for MODEL 4310 PSARRAY2 EEG ELECTRODE?

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

What is the FDA product code for MODEL 4310 PSARRAY2 EEG ELECTRODE?

The FDA product code for MODEL 4310 PSARRAY2 EEG ELECTRODE is GXY.

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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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