NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
FDA 510(k) clearance K112881 · decided 2012-05-22
Clearance details
- K-number
- K112881
- Device name
- NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
- Applicant
- Nexstim OY
- Decision
- Substantially Equivalent
- Date received
- 2011-09-30
- Decision date
- 2012-05-22
- Days to decision
- 235 days
- Clearance type
- Traditional
- Product code
- GWF
- Device class
- 2
- Regulation number
- 882.1870
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Helsinki, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw ver recall (Z-2320-2017) | Nexstim PLC | 2017-05-22 |