FDA 510(k)

NEUROLINE, SUBDERMAL NEEDLE ELECTRODES

K-Number: K020907 · 2002-06-14

Decision Date2002-06-14

Product CodeIKT

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

NEUROLINE, SUBDERMAL NEEDLE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Medicotest A/S. It received FDA 510(k) clearance on 2002-06-14 under 510(k) number K020907. 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 NEUROLINE, SUBDERMAL NEEDLE ELECTRODES?

NEUROLINE, SUBDERMAL NEEDLE ELECTRODES is a medical device that received FDA 510(k) clearance on 2002-06-14. The listed applicant is Medicotest A/S. The 510(k) number is K020907.

When did NEUROLINE, SUBDERMAL NEEDLE ELECTRODES receive FDA 510(k) clearance?

NEUROLINE, SUBDERMAL NEEDLE ELECTRODES received FDA 510(k) clearance on 2002-06-14, under 510(k) number K020907.

Who is the listed applicant for NEUROLINE, SUBDERMAL NEEDLE ELECTRODES?

The FDA 510(k) record lists Medicotest A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROLINE, SUBDERMAL NEEDLE ELECTRODES?

The FDA product code for NEUROLINE, SUBDERMAL NEEDLE ELECTRODES is IKT.

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Other records listing Medicotest A/S 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.