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FDA 510(k)

LEKTROGEL, MODEL LK3001

K-Number: K030887 · 2003-06-13

ApplicantInmed Ltda.
Decision Date2003-06-13
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LEKTROGEL, MODEL LK3001 is the device name listed in this FDA 510(k) record. The listed applicant is Inmed Ltda.. It received FDA 510(k) clearance on 2003-06-13 under 510(k) number K030887. 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 LEKTROGEL, MODEL LK3001?

LEKTROGEL, MODEL LK3001 is a medical device that received FDA 510(k) clearance on 2003-06-13. The listed applicant is Inmed Ltda.. The 510(k) number is K030887.

When did LEKTROGEL, MODEL LK3001 receive FDA 510(k) clearance?

LEKTROGEL, MODEL LK3001 received FDA 510(k) clearance on 2003-06-13, under 510(k) number K030887.

Who is the listed applicant for LEKTROGEL, MODEL LK3001?

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

What is the FDA product code for LEKTROGEL, MODEL LK3001?

The FDA product code for LEKTROGEL, MODEL LK3001 is GYB.

Related Clinical Trials

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Other records listing Inmed Ltda. 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.

K030081CSF400 AND CSF600K030889ULTRAEKOGEL MODELS EK 2000 & EK 2001

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.K221724Conductive GelTone-A-Matic International, Inc.K212325EEG-acpSomnomedics GmbHK212326AC Cream - Conductive pasteSpes Medica Srl

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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