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FDA 510(k)

Conductive Gel

K-Number: K221724 · 2022-09-23

ApplicantTone-A-Matic International, Inc.
Decision Date2022-09-23
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Conductive Gel is the device name listed in this FDA 510(k) record. The listed applicant is Tone-A-Matic International, Inc.. It received FDA 510(k) clearance on 2022-09-23 under 510(k) number K221724. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Conductive Gel?

Conductive Gel is a medical device that received FDA 510(k) clearance on 2022-09-23. The listed applicant is Tone-A-Matic International, Inc.. The 510(k) number is K221724.

When did Conductive Gel receive FDA 510(k) clearance?

Conductive Gel received FDA 510(k) clearance on 2022-09-23, under 510(k) number K221724.

Who is the listed applicant for Conductive Gel?

The FDA 510(k) record lists Tone-A-Matic International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Conductive Gel?

The FDA product code for Conductive Gel is GYB.

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Other records listing Tone-A-Matic International, 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.

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Related Devices (Code: GYB)

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.

K243749Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd.K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc.K222770Conductive GelTop-Rank Health Care Co., Ltd.K212325EEG-acpSomnomedics GmbHK212326AC Cream - Conductive pasteSpes Medica SrlK212787GT5 conductive & abrasive gelWuhan Greentek Pty , Ltd.

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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