Dantec Electrodes Model Dne 116, 117 & 13P02/12
FDA 510(k) K896874 · Dantec Medical, Inc.
510(k) numberK896874
Submission
- Device name
- Dantec Electrodes Model Dne 116, 117 & 13P02/12
- Applicant
- Dantec Medical, Inc.
Washington, DC, US - Received
- December 8, 1989
- Decision date
- June 18, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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More from Ambu A/S
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|---|---|---|
| K960503 | Dantec DuetFEN · Traditional | 09/16/1996SE |
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| K953999 | Dantec Da CapoEXY · Traditional | 11/21/1995SE |
| K926363 | Multi-Dop SIYO · Traditional | 06/19/1995SE |
| K931801 | Multi-Dop XIYO · Traditional | 06/14/1995SE |
| K930458 | Multi-Dop LIYN · Traditional | 02/03/1995SE |
| K932059 | Needle Electrodes and Disposable Scalp ElectrodeIKT · Traditional | 10/04/1994SE |
| K934580 | Dantec 13R45 Bar ElectrodeGXY · Traditional | 09/26/1994SE |
| K931966 | Dantec Disposable Concentric NeedleIKT · Traditional | 03/30/1994SE |
| K931923 | Dantec Maglite Magnetic Stimulator (Maglite)GWF · Traditional | 11/09/1993SE |
Questions and answers
When was Dantec Electrodes Model Dne 116, 117 & 13P02/12 cleared by the FDA?
Dantec Electrodes Model Dne 116, 117 & 13P02/12 (K896874) received a 510(k) decision of Substantially Equivalent on June 18, 1990, 192 days after the submission was received.
What is the product code of K896874?
The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.