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FDA 510(k)

SLE EMG ELECTRODES AND ACCESSORIES

K-Number: K981004 · 1998-10-21

ApplicantSpecialized Laboratory Equipment, Ltd.
Decision Date1998-10-21
Product CodeIKT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SLE EMG ELECTRODES AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Specialized Laboratory Equipment, Ltd.. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K981004. 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 SLE EMG ELECTRODES AND ACCESSORIES?

SLE EMG ELECTRODES AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Specialized Laboratory Equipment, Ltd.. The 510(k) number is K981004.

When did SLE EMG ELECTRODES AND ACCESSORIES receive FDA 510(k) clearance?

SLE EMG ELECTRODES AND ACCESSORIES received FDA 510(k) clearance on 1998-10-21, under 510(k) number K981004.

Who is the listed applicant for SLE EMG ELECTRODES AND ACCESSORIES?

The FDA 510(k) record lists Specialized Laboratory Equipment, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLE EMG ELECTRODES AND ACCESSORIES?

The FDA product code for SLE EMG ELECTRODES AND ACCESSORIES is IKT.

Related Clinical Trials

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.

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Other records listing Specialized Laboratory Equipment, Ltd. 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.

K980410SLE ELECTRODES AND ACCESSORIES

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 LimitedK161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing LimitedK152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesBio Protech, Inc.K120342EMG RECORDING ELECTRODE ASSEMBLYRhythmlink International, LLCK112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESCarefusion 209, 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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