FDA 510(k)

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS

K-Number: K912282 · 1992-03-16

Decision Date1992-03-16

Product CodeIKT

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS 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 1992-03-16 under 510(k) number K912282. The device is classified under product code IKT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS?

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS is a medical device that received FDA 510(k) clearance on 1992-03-16. The listed applicant is Chalgren Enterprises, Inc.. The 510(k) number is K912282.

When did DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS receive FDA 510(k) clearance?

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS received FDA 510(k) clearance on 1992-03-16, under 510(k) number K912282.

Who is the listed applicant for DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS?

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 DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS?

The FDA product code for DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS is IKT.

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Other records listing Chalgren Enterprises, Inc. as applicant

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Related Devices (Code: IKT)

K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)Technomed Europe K173815Allergan Botox Needle ElectrodeNatus Manufacturing Limited K161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing Limited K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesBio Protech, Inc.K120342EMG RECORDING ELECTRODE ASSEMBLYRhythmlink International, LLC K112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESCarefusion 209, Inc.

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.