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FDA 510(k)

NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE

K-Number: K932059 · 1994-10-04

ApplicantDantec Medical, Inc.
Decision Date1994-10-04
Product CodeIKT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Medical, Inc.. It received FDA 510(k) clearance on 1994-10-04 under 510(k) number K932059. 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 NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE?

NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE is a medical device that received FDA 510(k) clearance on 1994-10-04. The listed applicant is Dantec Medical, Inc.. The 510(k) number is K932059.

When did NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE receive FDA 510(k) clearance?

NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE received FDA 510(k) clearance on 1994-10-04, under 510(k) number K932059.

Who is the listed applicant for NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE?

The FDA 510(k) record lists Dantec Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE?

The FDA product code for NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE is IKT.

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Other records listing Dantec Medical, Inc. 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.

K960503DANTEC DUETK950314DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)K953999DANTEC DA CAPOK926363MULTI-DOP SK931801MULTI-DOP XK930458MULTI-DOP L

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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

View on FDA Database →

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

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