Data / Medical devices / Netherlands / Brain Science Tools BV
Brain Science Tools BV: FDA-registered device maker in De Bilt Utrecht, Netherlands, 1 510(k) clearance
Brain Science Tools BV is registered with the FDA (registration 3014251656) in De Bilt Utrecht, Netherlands. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 6, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014251656
- Address
- Bunnikseweg 39, De Bilt Utrecht, Netherlands, 3732HV
- Owner or operator
- Brain Science Tools BV (10078672)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 1, 2020
- Registered through
- 2026
- Brand names listed
- Neural Navigator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electromyograph, Diagnostic | IKN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Neurological Stereotaxic Instrument | HAW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Evoked Response | GWF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transcranial Magnetic Stimulator | OBP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 6, 2020 | K191422 | Neural Navigator | HAW | Substantially Equivalent | Soterix Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transcranial Magnetic Stimulator
- All makers of Stimulator, Electrical, Evoked Response
- All makers of Neurological Stereotaxic Instrument
- All makers of Electromyograph, Diagnostic
Updated April 6, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.