FDA 510(k)

ECG ELECTRODE

K-Number: K944655 · 1994-11-22

Decision Date1994-11-22

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ECG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Andover Medical, Inc.. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K944655. 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?

ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Conmed Andover Medical, Inc.. The 510(k) number is K944655.

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

ECG ELECTRODE received FDA 510(k) clearance on 1994-11-22, under 510(k) number K944655.

Who is the listed applicant for ECG ELECTRODE?

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

What is the FDA product code for ECG ELECTRODE?

The FDA product code for ECG ELECTRODE is DRX.

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Other records listing Conmed Andover Medical, Inc. as applicant

K9458361800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORING ECG ELECTRODES K9462731700 MONITORING ECG ELECTRODE K9447261710 MONITORING ECG ELECTRODE K9448492700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE K942718CLOTH TENS/BNES ELECTRODE K941839DISPOSABLE SURGICAL CABLE

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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

View on FDA Database →

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