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FDA 510(k)

AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES

K-Number: K050194 · 2005-04-26

ApplicantAxon Systems, Inc.
Decision Date2005-04-26
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Axon Systems, Inc.. It received FDA 510(k) clearance on 2005-04-26 under 510(k) number K050194. 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 AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES?

AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES is a medical device that received FDA 510(k) clearance on 2005-04-26. The listed applicant is Axon Systems, Inc.. The 510(k) number is K050194.

When did AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES receive FDA 510(k) clearance?

AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES received FDA 510(k) clearance on 2005-04-26, under 510(k) number K050194.

Who is the listed applicant for AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES?

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

What is the FDA product code for AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES?

The FDA product code for AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES is GXZ.

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Other records listing Axon Systems, Inc. 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.

K090838STIMULUS/DISSECTION INSTRUMENTSK062996DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBESK062198SUNSPOTS PRE-GELLED SURFACE ELECTRODESK061639ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMONK061113ORTHOMONK050798ECLIPSE NEUROLOGICAL WORKSTATION

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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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