Nexstim Eximia Navigated Brain Stimulation System
FDA 510(k) K091457 · Nexstim OY
510(k) numberK091457
Submission
- Device name
- Nexstim Eximia Navigated Brain Stimulation System
- Applicant
- Nexstim OY
North Attleboro, MA, US - Received
- May 18, 2009
- Decision date
- December 8, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
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More from Alphatec Spine, Inc.
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| K182700 | Nexstim Navigated Brain Therapy (NBT) System 2OBP · Traditional | 03/22/2019SE |
| K171902 | Nexstim Navigated Brain Therapy (NBT) System 2OBP · Traditional | 11/10/2017SE |
| K112881 | Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with…GWF · Traditional | 05/22/2012SE |
Questions and answers
When was Nexstim Eximia Navigated Brain Stimulation System cleared by the FDA?
Nexstim Eximia Navigated Brain Stimulation System (K091457) received a 510(k) decision of Substantially Equivalent on December 8, 2009, 204 days after the submission was received.
What is the product code of K091457?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.