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FDA 510(k)

DISPOSABLE ECG ELECTRODE

K-Number: K953649 · 1996-06-21

ApplicantKendall-Ltp
Decision Date1996-06-21
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ECG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Kendall-Ltp. It received FDA 510(k) clearance on 1996-06-21 under 510(k) number K953649. 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 DISPOSABLE ECG ELECTRODE?

DISPOSABLE ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Kendall-Ltp. The 510(k) number is K953649.

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

DISPOSABLE ECG ELECTRODE received FDA 510(k) clearance on 1996-06-21, under 510(k) number K953649.

Who is the listed applicant for DISPOSABLE ECG ELECTRODE?

The FDA 510(k) record lists Kendall-Ltp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE ECG ELECTRODE?

The FDA product code for DISPOSABLE ECG ELECTRODE is DRX.

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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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