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FDA 510(k)

ECG ELECTRODE (VARIOUS)

K-Number: K991105 · 1999-11-26

ApplicantConmedcorp
Decision Date1999-11-26
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG ELECTRODE (VARIOUS) is the device name listed in this FDA 510(k) record. The listed applicant is Conmedcorp. It received FDA 510(k) clearance on 1999-11-26 under 510(k) number K991105. 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 (VARIOUS)?

ECG ELECTRODE (VARIOUS) is a medical device that received FDA 510(k) clearance on 1999-11-26. The listed applicant is Conmedcorp. The 510(k) number is K991105.

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

ECG ELECTRODE (VARIOUS) received FDA 510(k) clearance on 1999-11-26, under 510(k) number K991105.

Who is the listed applicant for ECG ELECTRODE (VARIOUS)?

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

What is the FDA product code for ECG ELECTRODE (VARIOUS)?

The FDA product code for ECG ELECTRODE (VARIOUS) 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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