FDA 510(k)

NIKOMED TRACE 1 ECG ELECTRODES

K-Number: K022909 · 2003-01-09

Decision Date2003-01-09

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NIKOMED TRACE 1 ECG ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Nikomed U.S.A., Inc.. It received FDA 510(k) clearance on 2003-01-09 under 510(k) number K022909. 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 NIKOMED TRACE 1 ECG ELECTRODES?

NIKOMED TRACE 1 ECG ELECTRODES is a medical device that received FDA 510(k) clearance on 2003-01-09. The listed applicant is Nikomed U.S.A., Inc.. The 510(k) number is K022909.

When did NIKOMED TRACE 1 ECG ELECTRODES receive FDA 510(k) clearance?

NIKOMED TRACE 1 ECG ELECTRODES received FDA 510(k) clearance on 2003-01-09, under 510(k) number K022909.

Who is the listed applicant for NIKOMED TRACE 1 ECG ELECTRODES?

The FDA 510(k) record lists Nikomed U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIKOMED TRACE 1 ECG ELECTRODES?

The FDA product code for NIKOMED TRACE 1 ECG ELECTRODES is DRX.

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Other records listing Nikomed U.S.A., Inc. as applicant

K000079NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M K950473DISPOSABLE ECG MONITORING ELECTRODE K950475DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 K950472DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM K950480DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM K950471DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM

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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.