FDA 510(k)

CONCENTRIC ELECTRODE TYPE #13R01, 13R02

K-Number: K895460 · 1990-06-18

Decision Date1990-06-18

Product CodeIKT

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

CONCENTRIC ELECTRODE TYPE #13R01, 13R02 is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Electronics, Inc.. It received FDA 510(k) clearance on 1990-06-18 under 510(k) number K895460. 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 CONCENTRIC ELECTRODE TYPE #13R01, 13R02?

CONCENTRIC ELECTRODE TYPE #13R01, 13R02 is a medical device that received FDA 510(k) clearance on 1990-06-18. The listed applicant is Dantec Electronics, Inc.. The 510(k) number is K895460.

When did CONCENTRIC ELECTRODE TYPE #13R01, 13R02 receive FDA 510(k) clearance?

CONCENTRIC ELECTRODE TYPE #13R01, 13R02 received FDA 510(k) clearance on 1990-06-18, under 510(k) number K895460.

Who is the listed applicant for CONCENTRIC ELECTRODE TYPE #13R01, 13R02?

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

What is the FDA product code for CONCENTRIC ELECTRODE TYPE #13R01, 13R02?

The FDA product code for CONCENTRIC ELECTRODE TYPE #13R01, 13R02 is IKT.

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Other records listing Dantec Electronics, Inc. as applicant

K894911SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 K884915DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER K881915DANTEC MAGNETIC STIMULATOR K874758DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE K87475913L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE K874735DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE

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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

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