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FDA 510(k)

FOAM ECG ELECTRODE, 2060 AND 2061

K-Number: K770988 · 1977-06-14

ApplicantCardio-Dynamics Laboratories, Inc.
Decision Date1977-06-14
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOAM ECG ELECTRODE, 2060 AND 2061 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 1977-06-14 under 510(k) number K770988. 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 FOAM ECG ELECTRODE, 2060 AND 2061?

FOAM ECG ELECTRODE, 2060 AND 2061 is a medical device that received FDA 510(k) clearance on 1977-06-14. The listed applicant is Cardio-Dynamics Laboratories, Inc.. The 510(k) number is K770988.

When did FOAM ECG ELECTRODE, 2060 AND 2061 receive FDA 510(k) clearance?

FOAM ECG ELECTRODE, 2060 AND 2061 received FDA 510(k) clearance on 1977-06-14, under 510(k) number K770988.

Who is the listed applicant for FOAM ECG ELECTRODE, 2060 AND 2061?

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 FOAM ECG ELECTRODE, 2060 AND 2061?

The FDA product code for FOAM ECG ELECTRODE, 2060 AND 2061 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 SPEEDK781514ECG ELECTRODE, 2021, 2022, 2032, 2033K781152ELECTROCARDIOGRAPHIC ECG RECORDER

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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