FDA 510(k)

EKG ELECTRODES, DISPOSABLE

K-Number: K781940 · 1978-11-29

Decision Date1978-11-29

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EKG ELECTRODES, DISPOSABLE 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 1978-11-29 under 510(k) number K781940. 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 EKG ELECTRODES, DISPOSABLE?

EKG ELECTRODES, DISPOSABLE is a medical device that received FDA 510(k) clearance on 1978-11-29. The listed applicant is Hayes Products, Inc.. The 510(k) number is K781940.

When did EKG ELECTRODES, DISPOSABLE receive FDA 510(k) clearance?

EKG ELECTRODES, DISPOSABLE received FDA 510(k) clearance on 1978-11-29, under 510(k) number K781940.

Who is the listed applicant for EKG ELECTRODES, DISPOSABLE?

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 EKG ELECTRODES, DISPOSABLE?

The FDA product code for EKG ELECTRODES, DISPOSABLE is DRX.

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Other records listing Hayes Products, Inc. as applicant

K790883STRESS/EMERGENCY EELCTRODE K791139PREGELLED DISPOSABLE ECG ELECTRODES K791140PREGELLED DISPOSABLE EELCTRO. SERIES 600 K771447PREGELLED DISP. EKG MONITORING ELECT-

Related Devices (Code: DRX)

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology Corporation K101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process Sas K100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/S K093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.