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FDA 510(k)

DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)

K-Number: K896370 · 1989-12-22

ApplicantChalgren Enterprises, Inc.
Decision Date1989-12-22
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) is the device name listed in this FDA 510(k) record. The listed applicant is Chalgren Enterprises, Inc.. It received FDA 510(k) clearance on 1989-12-22 under 510(k) number K896370. 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 DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)?

DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) is a medical device that received FDA 510(k) clearance on 1989-12-22. The listed applicant is Chalgren Enterprises, Inc.. The 510(k) number is K896370.

When did DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) receive FDA 510(k) clearance?

DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) received FDA 510(k) clearance on 1989-12-22, under 510(k) number K896370.

Who is the listed applicant for DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)?

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

What is the FDA product code for DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)?

The FDA product code for DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) is GXZ.

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Other records listing Chalgren Enterprises, 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.

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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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