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FDA 510(k)

ECG-GEL ELECTRODE GEL

K-Number: K833172 · 1983-11-21

ApplicantWhs Products, Inc.
Decision Date1983-11-21
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ECG-GEL ELECTRODE GEL is the device name listed in this FDA 510(k) record. The listed applicant is Whs Products, Inc.. It received FDA 510(k) clearance on 1983-11-21 under 510(k) number K833172. 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 ECG-GEL ELECTRODE GEL?

ECG-GEL ELECTRODE GEL is a medical device that received FDA 510(k) clearance on 1983-11-21. The listed applicant is Whs Products, Inc.. The 510(k) number is K833172.

When did ECG-GEL ELECTRODE GEL receive FDA 510(k) clearance?

ECG-GEL ELECTRODE GEL received FDA 510(k) clearance on 1983-11-21, under 510(k) number K833172.

Who is the listed applicant for ECG-GEL ELECTRODE GEL?

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

What is the FDA product code for ECG-GEL ELECTRODE GEL?

The FDA product code for ECG-GEL ELECTRODE GEL is GYB.

Related Clinical Trials

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Other records listing Whs Products, 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.

K834088GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLINGK828673RICH-MAR ULTRASOUND COUPLING LOTIONK827885BIO-DERM COUPLING LOTION

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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