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FDA 510(k)

ELECTRODE

K-Number: K050248 · 2005-05-25

ApplicantElectramold
Decision Date2005-05-25
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Electramold. It received FDA 510(k) clearance on 2005-05-25 under 510(k) number K050248. 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 ELECTRODE?

ELECTRODE is a medical device that received FDA 510(k) clearance on 2005-05-25. The listed applicant is Electramold. The 510(k) number is K050248.

When did ELECTRODE receive FDA 510(k) clearance?

ELECTRODE received FDA 510(k) clearance on 2005-05-25, under 510(k) number K050248.

Who is the listed applicant for ELECTRODE?

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

What is the FDA product code for ELECTRODE?

The FDA product code for ELECTRODE is DRX.

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Related PubMed Literature

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.

PMID: 31472187A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic.Journal of neuroscience methods ()

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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