Dantec Maglite Magnetic Stimulator (Maglite)
FDA 510(k) K931923 · Dantec Medical, Inc.
510(k) numberK931923
Submission
- Device name
- Dantec Maglite Magnetic Stimulator (Maglite)
- Applicant
- Dantec Medical, Inc.
Washington, DC, US - Received
- April 16, 1993
- Decision date
- November 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K931801 | Multi-Dop XIYO · Traditional | 06/14/1995SE |
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| 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 |
| K926516 | Dantec Magnetic Stimulator MagproGWF · Traditional | 08/31/1993SE |
Questions and answers
When was Dantec Maglite Magnetic Stimulator (Maglite) cleared by the FDA?
Dantec Maglite Magnetic Stimulator (Maglite) (K931923) received a 510(k) decision of Substantially Equivalent on November 9, 1993, 207 days after the submission was received.
What is the product code of K931923?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.