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FDA 510(k)

PREGELLED DISPOSABLE ECG ELECTRODES

K-Number: K791139 · 1979-07-10

ApplicantHayes Products, Inc.
Decision Date1979-07-10
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PREGELLED DISPOSABLE ECG ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Hayes Products, Inc.. It received FDA 510(k) clearance on 1979-07-10 under 510(k) number K791139. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREGELLED DISPOSABLE ECG ELECTRODES?

PREGELLED DISPOSABLE ECG ELECTRODES is a medical device that received FDA 510(k) clearance on 1979-07-10. The listed applicant is Hayes Products, Inc.. The 510(k) number is K791139.

When did PREGELLED DISPOSABLE ECG ELECTRODES receive FDA 510(k) clearance?

PREGELLED DISPOSABLE ECG ELECTRODES received FDA 510(k) clearance on 1979-07-10, under 510(k) number K791139.

Who is the listed applicant for PREGELLED DISPOSABLE ECG ELECTRODES?

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

What is the FDA product code for PREGELLED DISPOSABLE ECG ELECTRODES?

The FDA product code for PREGELLED DISPOSABLE ECG ELECTRODES is DRX.

Related Clinical Trials

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Other records listing Hayes 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.

K790883STRESS/EMERGENCY EELCTRODEK791140PREGELLED DISPOSABLE EELCTRO. SERIES 600K781940EKG ELECTRODES, DISPOSABLEK771447PREGELLED DISP. EKG MONITORING ELECT-

Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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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