Sle Emg Electrodes and Accessories
FDA 510(k) K981004 · Specialized Laboratory Equipment, Ltd.
510(k) numberK981004
Submission
- Device name
- Sle Emg Electrodes and Accessories
- Applicant
- Specialized Laboratory Equipment, Ltd.
Chico, CA, US - Received
- March 18, 1998
- Decision date
- October 21, 1998
- 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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|---|---|---|---|
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| K173815 | Allergan Botox Needle ElectrodeIKT · Traditional | Natus Manufacturing Limited | 06/29/2018SE |
| K161430 | Myoject Luer Lock Needle ElectrodeIKT · Traditional | Natus Manufacturing Limited | 03/02/2017SE |
| K152984 | Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…IKT · Traditional | Bio Protech, Inc. | 06/03/2016SE |
| 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 |
More from Ambu A/S
| 510(k) | Device | Decision |
|---|---|---|
| K980410 | Sle Electrodes and AccessoriesGXY · Traditional | 10/22/1998SE |
Questions and answers
When was Sle Emg Electrodes and Accessories cleared by the FDA?
Sle Emg Electrodes and Accessories (K981004) received a 510(k) decision of Substantially Equivalent on October 21, 1998, 217 days after the submission was received.
What is the product code of K981004?
The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.