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FDA 510(k)

GRAHAM-FIELD SALINE ELECTROLYTE GEL

K-Number: K944600 · 1995-11-20

ApplicantChester Labs, Inc.
Decision Date1995-11-20
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GRAHAM-FIELD SALINE ELECTROLYTE GEL is the device name listed in this FDA 510(k) record. The listed applicant is Chester Labs, Inc.. It received FDA 510(k) clearance on 1995-11-20 under 510(k) number K944600. 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 GRAHAM-FIELD SALINE ELECTROLYTE GEL?

GRAHAM-FIELD SALINE ELECTROLYTE GEL is a medical device that received FDA 510(k) clearance on 1995-11-20. The listed applicant is Chester Labs, Inc.. The 510(k) number is K944600.

When did GRAHAM-FIELD SALINE ELECTROLYTE GEL receive FDA 510(k) clearance?

GRAHAM-FIELD SALINE ELECTROLYTE GEL received FDA 510(k) clearance on 1995-11-20, under 510(k) number K944600.

Who is the listed applicant for GRAHAM-FIELD SALINE ELECTROLYTE GEL?

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

What is the FDA product code for GRAHAM-FIELD SALINE ELECTROLYTE GEL?

The FDA product code for GRAHAM-FIELD SALINE ELECTROLYTE GEL is GYB.

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Other records listing Chester Labs, 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.

K041060E-Z LUBRICATING JELLYK001705STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GFK001593MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GELK944598GRAHAM-FIELD ELECTRODE CONDUCTIVITY GELK944599GRAHAM-FIELD CONDUCTIVE ECG SPRAYK944597GRAHAM-FIELD ULTRASOUND SCANNING GEL

View all 11 devices →

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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