Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
FDA 510(k) K990375 · Medtronic Functional Diagnostics A/S
510(k) numberK990375
Submission
- Device name
- Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
- Applicant
- Medtronic Functional Diagnostics A/S
Copenhagen, DK - Received
- February 8, 1999
- Decision date
- March 9, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
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| K011471 | Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber ProberFFX · Traditional | 11/08/2002SE |
| K002992 | Disposable Hypodermic Needle Electrode, Model 9013S0421,9013S0431,9013S0441,9013S0451,901…IKT · Traditional | 08/15/2001SE |
| K011472 | Polygram 98 Anorectal Function Testing Application, Polygram 98 Esophageal Manometry…FFX · Traditional | 08/10/2001SE |
| K010130 | Polygram 98 Esophageal Manometry Testing Application, Model 9043S0103FFX · Special | 02/07/2001SE |
| K000386 | Polygram 98 Anorectal Function Testing Application, Model 9043S0111FFX · Traditional | 05/05/2000SE |
| K992715 | Neuro Urodynamic Suite, Model 9032E0101FEN · Traditional | 02/28/2000SE |
| K992713 | Polygraf Id, Polygram '98 Esophageal Manometry Testing Application, Models…FFX · Traditional | 11/10/1999SE |
| K991389 | Anorectal Manometry Suite, Model 9032S0201FFX · Traditional | 07/15/1999SE |
| K981733 | Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111FFX · Traditional | 02/04/1999SE |
Questions and answers
When was Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 cleared by the FDA?
Disposable Monopolar Needle Electrode, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 (K990375) received a 510(k) decision of Substantially Equivalent on March 9, 1999, 29 days after the submission was received.
What is the product code of K990375?
The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.