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FDA 510(k)

DISPOSABLE MONITORING ELECTRODES

K-Number: K041954 · 2004-09-15

ApplicantShanghai Intco Electrode Manufacturing Co., Ltd.
Decision Date2004-09-15
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE MONITORING ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Intco Electrode Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2004-09-15 under 510(k) number K041954. 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 MONITORING ELECTRODES?

DISPOSABLE MONITORING ELECTRODES is a medical device that received FDA 510(k) clearance on 2004-09-15. The listed applicant is Shanghai Intco Electrode Manufacturing Co., Ltd.. The 510(k) number is K041954.

When did DISPOSABLE MONITORING ELECTRODES receive FDA 510(k) clearance?

DISPOSABLE MONITORING ELECTRODES received FDA 510(k) clearance on 2004-09-15, under 510(k) number K041954.

Who is the listed applicant for DISPOSABLE MONITORING ELECTRODES?

The FDA 510(k) record lists Shanghai Intco Electrode Manufacturing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE MONITORING ELECTRODES?

The FDA product code for DISPOSABLE MONITORING ELECTRODES 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 Shanghai Intco Electrode Manufacturing Co., Ltd. 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.

K093327INTCO TAB ELECTRODE

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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