Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,
FDA 510(k) K091410 · Spes Medica Srl
510(k) numberK091410
Submission
- Device name
- Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot,
- Applicant
- Spes Medica Srl
Battipaglia, IT - Received
- May 13, 2009
- Decision date
- August 11, 2009
- 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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| 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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| K212326 | AC Cream - Conductive pasteGYB · Traditional | 12/01/2021SE |
| K192606 | SAC2 - Electrode CreamGYB · Traditional | 01/17/2020SE |
| K192603 | Spes Medica Subdermal Needle ElectrodesGXZ · Traditional | 11/22/2019SE |
| K190050 | Tech Dots - Adhesive and conductive gelGYB · Traditional | 07/19/2019SE |
| K133348 | Stim ProbeETN · Traditional | 11/21/2014SE |
| K120494 | Disposable Adhesive Surface ElectrodeGXY · Traditional | 06/11/2012SE |
| K093373 | Laryngeal Surface ElectrodeETN · Traditional | 08/24/2010SE |
Questions and answers
When was Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot, cleared by the FDA?
Disposable Emg Needle Electrodes, Myoline, Myoline 2, Myobot, (K091410) received a 510(k) decision of Substantially Equivalent on August 11, 2009, 90 days after the submission was received.
What is the product code of K091410?
The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.