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FDA 510(k)

RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES

K-Number: K022914 · 2002-12-20

ApplicantRhythmlink International, LLC
Decision Date2002-12-20
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Rhythmlink International, LLC. It received FDA 510(k) clearance on 2002-12-20 under 510(k) number K022914. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES?

RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES is a medical device that received FDA 510(k) clearance on 2002-12-20. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K022914.

When did RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES receive FDA 510(k) clearance?

RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES received FDA 510(k) clearance on 2002-12-20, under 510(k) number K022914.

Who is the listed applicant for RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES?

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

What is the FDA product code for RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES?

The FDA product code for RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES is GXZ.

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Other records listing Rhythmlink International, LLC as applicant

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Related Devices (Code: GXZ)

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.

K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed EuropeK232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.K200984Guardian Needle ElectrodeRhythmlink International, LLCK192603Spes Medica Subdermal Needle ElectrodesSpes Medica SrlK190801PressOn Electrode HeadsetRhythmlink International, LLC

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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