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FDA 510(k)

ECA GEL

K-Number: K792488 · 1980-02-05

ApplicantVanaray Laboratories, Inc.
Decision Date1980-02-05
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ECA GEL is the device name listed in this FDA 510(k) record. The listed applicant is Vanaray Laboratories, Inc.. It received FDA 510(k) clearance on 1980-02-05 under 510(k) number K792488. 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 ECA GEL?

ECA GEL is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Vanaray Laboratories, Inc.. The 510(k) number is K792488.

When did ECA GEL receive FDA 510(k) clearance?

ECA GEL received FDA 510(k) clearance on 1980-02-05, under 510(k) number K792488.

Who is the listed applicant for ECA GEL?

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

What is the FDA product code for ECA GEL?

The FDA product code for ECA GEL is GYB.

Other records listing Vanaray Laboratories, 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.

K802647ECA GEL PROUDUCT REFORMULATIONK802648UCA CREAM PRODUCT REFORMULATIONK802650UCA LOTION PRODUCT REFORMULATIONK802649UCA GEL PRODUCT REFORMAULATIONK801383ECA CREAM REFORMULATIONK792490UCA LOTION

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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.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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