Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled
FDA 510(k) K062437 · Technomed Europe
510(k) numberK062437
Submission
- Device name
- Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled
- Applicant
- Technomed Europe
Maastricht-Airport, NL - Received
- August 11, 2006
- Decision date
- February 16, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IKT – Electrode, Needle, Diagnostic Electromyograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1385
- Specialty
- Physical Medicine
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| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…IKT · Traditional | Technomed Europe | 03/15/2026SE |
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| K143433 | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable…IKT · Traditional | Natus Manufacturing Limited | 08/28/2015SE |
| K120342 | Emg Recording Electrode AssemblyIKT · Traditional | Rhythmlink International, LLC | 06/22/2012SE |
| K112034 | Teca Elite Disposable Concentric NeedlesIKT · Special | Carefusion 209, Inc. | 08/12/2011SE |
| K111131 | Teca (TM) Elite Disposable Monopolar NeedlesIKT · Special | Carefusion 209, Inc. | 06/17/2011SE |
| K092973 | Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleIKT · Traditional | Bionen S.A.S. | 10/07/2010SE |
| K093825 | Ambu Neuroline Disposable Inoject Needle ElectrodeIKT · Special | Ambu A/S | 01/13/2010SE |
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| 510(k) | Device | Decision |
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| K254183 | MR Conditional Cup ElectrodesGXY · Traditional | 05/07/2026SE |
| K253581 | Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…IKT · Traditional | 03/15/2026SE |
| K241045 | Disposable Subdermal Needle Electrode, CorkscrewGXZ · Traditional | 12/11/2024SE |
| K130136 | Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal…GXZ · Traditional | 07/19/2013SE |
| K121257 | Laryngeal ElectrodeETN · Traditional | 08/28/2012SE |
| K110422 | Surgical StimulatorsETN · Traditional | 05/26/2011SE |
| K073532 | Disposable Adhesive Surface Electrodes, Disc ElectrodesGXY · Traditional | 05/01/2008SE |
| K072016 | Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride…GXY · Traditional | 10/19/2007SE |
| K063729 | Disposable Pedicle Screw Probe, Model 3603-00GXZ · Traditional | 08/21/2007SE |
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Questions and answers
When was Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled cleared by the FDA?
Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled (K062437) received a 510(k) decision of Substantially Equivalent on February 16, 2007, 189 days after the submission was received.
What is the product code of K062437?
The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.