Dantec Magnetic Stimulator
FDA 510(k) K881915 · Dantec Electronics, Inc.
510(k) numberK881915
Submission
- Device name
- Dantec Magnetic Stimulator
- Applicant
- Dantec Electronics, Inc.
Allendale, NJ, US - Received
- May 9, 1988
- Decision date
- October 17, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K243495 | Natus Ultrapro S100 (982A0594)GWF · Special | Natus Neurology Incorporated | 12/12/2024SE |
| K242345 | Delphi StimulatorGWF · Traditional | Quantalx Neuroscience | 11/05/2024SE |
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| K230415 | Cadwell GuardianGWF · Traditional | Cadwell Industries, Inc. | 08/17/2023SE |
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More from Alphatec Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K895460 | Concentric Electrode Type #13R01, 13R02IKT · Traditional | 06/18/1990SE |
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| K884915 | Dantec 22K60/61/62 Catheter Tip TransducerFAP · Traditional | 10/04/1989SE |
| K874759 | 13L81 Disposable Sphincter Electrode, 13L33 CableFAP · Traditional | 04/14/1988SE |
| K874758 | Dantec 13L40 St. Marks's Pudendal ElectrodeFAP · Traditional | 04/14/1988SE |
| K874735 | Dantec 13L35/36/37 Stim. and Recording ElectrodeGXY · Traditional | 01/22/1988SE |
| K870567 | Evoport 300GWF · Traditional | 10/06/1987SE |
| K872106 | Dantec CounterpointGWF · Traditional | 09/10/1987SE |
| K860368 | Urdyn 5000 (Uroflowmeter)FFO · Traditional | 04/23/1986SE |
| K853119 | Urodyn 1000FFO · Traditional | 10/04/1985SE |
Questions and answers
When was Dantec Magnetic Stimulator cleared by the FDA?
Dantec Magnetic Stimulator (K881915) received a 510(k) decision of Substantially Equivalent on October 17, 1988, 161 days after the submission was received.
What is the product code of K881915?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.