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FDA 510(k)

LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)

K-Number: K863135 · 1987-09-04

ApplicantNeurotechnics, Inc.
Decision Date1987-09-04
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP) is the device name listed in this FDA 510(k) record. The listed applicant is Neurotechnics, Inc.. It received FDA 510(k) clearance on 1987-09-04 under 510(k) number K863135. 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 LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)?

LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP) is a medical device that received FDA 510(k) clearance on 1987-09-04. The listed applicant is Neurotechnics, Inc.. The 510(k) number is K863135.

When did LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP) receive FDA 510(k) clearance?

LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP) received FDA 510(k) clearance on 1987-09-04, under 510(k) number K863135.

Who is the listed applicant for LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)?

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

What is the FDA product code for LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)?

The FDA product code for LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP) is GXZ.

Related Clinical Trials

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Other records listing Neurotechnics, 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.

K863136HIGH PROFILE NEEDLE ELECTRODE (N-SPYRAL HP)

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

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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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