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FDA 510(k)

EKG (ECG) ELECTRODES

K-Number: K821434 · 1982-07-30

ApplicantDupaco, Inc.
Decision Date1982-07-30
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EKG (ECG) ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Dupaco, Inc.. It received FDA 510(k) clearance on 1982-07-30 under 510(k) number K821434. 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 (ECG) ELECTRODES?

EKG (ECG) ELECTRODES is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is Dupaco, Inc.. The 510(k) number is K821434.

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

EKG (ECG) ELECTRODES received FDA 510(k) clearance on 1982-07-30, under 510(k) number K821434.

Who is the listed applicant for EKG (ECG) ELECTRODES?

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

What is the FDA product code for EKG (ECG) ELECTRODES?

The FDA product code for EKG (ECG) ELECTRODES is DRX.

Related Clinical Trials

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.

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Other records listing Dupaco, 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.

K841581UNIFILTER ANESTHESIA & RESPIRATORY FILTK830395PEEPERK770084OPERATING ROOM VENTILATOR

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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