FDA 510(k)

MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE

K-Number: K071186 · 2007-07-30

Decision Date2007-07-30

Product CodeIKT

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Ambu A/S. It received FDA 510(k) clearance on 2007-07-30 under 510(k) number K071186. 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 MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE?

MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE is a medical device that received FDA 510(k) clearance on 2007-07-30. The listed applicant is Ambu A/S. The 510(k) number is K071186.

When did MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE receive FDA 510(k) clearance?

MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE received FDA 510(k) clearance on 2007-07-30, under 510(k) number K071186.

Who is the listed applicant for MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE?

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

What is the FDA product code for MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE?

The FDA product code for MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE is IKT.

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Other records listing Ambu A/S as applicant

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set K260578Ambu® 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)K251583Ambu® Virobac II® Exhalation Filter K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2

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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.