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FDA 510(k)

EMG DISC RECORDING ELECTRODE WITH PIN

K-Number: K952908 · 1995-12-06

ApplicantChalgren Enterprises, Inc.
Decision Date1995-12-06
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMG DISC RECORDING ELECTRODE WITH PIN 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 1995-12-06 under 510(k) number K952908. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMG DISC RECORDING ELECTRODE WITH PIN?

EMG DISC RECORDING ELECTRODE WITH PIN is a medical device that received FDA 510(k) clearance on 1995-12-06. The listed applicant is Chalgren Enterprises, Inc.. The 510(k) number is K952908.

When did EMG DISC RECORDING ELECTRODE WITH PIN receive FDA 510(k) clearance?

EMG DISC RECORDING ELECTRODE WITH PIN received FDA 510(k) clearance on 1995-12-06, under 510(k) number K952908.

Who is the listed applicant for EMG DISC RECORDING ELECTRODE WITH PIN?

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 EMG DISC RECORDING ELECTRODE WITH PIN?

The FDA product code for EMG DISC RECORDING ELECTRODE WITH PIN is GXY.

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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.

K982950FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550K960591RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STPK955335DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODEK953356EMG RECORDING RING ELECTRODEK953361EMG DISC RECORDING ELECTRODEK953354EMG DISC RECORDING ELECTRODE

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Related Devices (Code: GXY)

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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

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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