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FDA 510(k)

ECG ELECTRODE, 2021, 2022, 2032, 2033

K-Number: K781514 · 1978-10-17

ApplicantCardio-Dynamics Laboratories, Inc.
Decision Date1978-10-17
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG ELECTRODE, 2021, 2022, 2032, 2033 is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Dynamics Laboratories, Inc.. It received FDA 510(k) clearance on 1978-10-17 under 510(k) number K781514. 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 ECG ELECTRODE, 2021, 2022, 2032, 2033?

ECG ELECTRODE, 2021, 2022, 2032, 2033 is a medical device that received FDA 510(k) clearance on 1978-10-17. The listed applicant is Cardio-Dynamics Laboratories, Inc.. The 510(k) number is K781514.

When did ECG ELECTRODE, 2021, 2022, 2032, 2033 receive FDA 510(k) clearance?

ECG ELECTRODE, 2021, 2022, 2032, 2033 received FDA 510(k) clearance on 1978-10-17, under 510(k) number K781514.

Who is the listed applicant for ECG ELECTRODE, 2021, 2022, 2032, 2033?

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

What is the FDA product code for ECG ELECTRODE, 2021, 2022, 2032, 2033?

The FDA product code for ECG ELECTRODE, 2021, 2022, 2032, 2033 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 Cardio-Dynamics Laboratories, 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.

K781911ECG ANALYZER, HIGH SPEEDK781152ELECTROCARDIOGRAPHIC ECG RECORDERK770988FOAM ECG ELECTRODE, 2060 AND 2061

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

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

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