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FDA 510(k)

BIO-DETEK EEG ELECTRODE

K-Number: K920352 · 1992-08-14

ApplicantBio-Detek, Inc.
Decision Date1992-08-14
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIO-DETEK EEG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Detek, Inc.. It received FDA 510(k) clearance on 1992-08-14 under 510(k) number K920352. 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 BIO-DETEK EEG ELECTRODE?

BIO-DETEK EEG ELECTRODE is a medical device that received FDA 510(k) clearance on 1992-08-14. The listed applicant is Bio-Detek, Inc.. The 510(k) number is K920352.

When did BIO-DETEK EEG ELECTRODE receive FDA 510(k) clearance?

BIO-DETEK EEG ELECTRODE received FDA 510(k) clearance on 1992-08-14, under 510(k) number K920352.

Who is the listed applicant for BIO-DETEK EEG ELECTRODE?

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

What is the FDA product code for BIO-DETEK EEG ELECTRODE?

The FDA product code for BIO-DETEK EEG ELECTRODE is GXZ.

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Other records listing Bio-Detek, Inc. 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.

K100565DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325K071321POCKETCPRK040256PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005K040056BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90K033771BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTORK984582ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX

View all 14 devices →

Related Devices (Code: GXZ)

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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