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FDA 510(k)

Myoject Luer Lock Needle Electrode

K-Number: K161430 · 2017-03-02

ApplicantNatus Manufacturing Limited
Decision Date2017-03-02
Product CodeIKT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Myoject Luer Lock Needle Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Natus Manufacturing Limited. It received FDA 510(k) clearance on 2017-03-02 under 510(k) number K161430. 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 Myoject Luer Lock Needle Electrode?

Myoject Luer Lock Needle Electrode is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Natus Manufacturing Limited. The 510(k) number is K161430.

When did Myoject Luer Lock Needle Electrode receive FDA 510(k) clearance?

Myoject Luer Lock Needle Electrode received FDA 510(k) clearance on 2017-03-02, under 510(k) number K161430.

Who is the listed applicant for Myoject Luer Lock Needle Electrode?

The FDA 510(k) record lists Natus Manufacturing Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Myoject Luer Lock Needle Electrode?

The FDA product code for Myoject Luer Lock Needle Electrode is IKT.

Other records listing Natus Manufacturing Limited 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.

K242346Grass® MR Conditional/CT Cup ElectrodesK173815Allergan Botox Needle Electrode

Related Devices (Code: IKT)

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.

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 EuropeK173815Allergan Botox Needle ElectrodeNatus Manufacturing LimitedK152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesBio Protech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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