FDA Product Code
FDA Product Code PIW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1450
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243426 | Nurochek-Pro System | Headsafe Mfg Pty, Ltd. | 2025-03-27 | Traditional | PDF ↗ |
| K231914 | Nurochek-II System | Headsafe Mfg Pty, Ltd. | 2023-12-27 | Traditional | PDF ↗ |
| K190815 | BrainScope TBI | Brainscope Company, Inc. | 2019-09-11 | Traditional | PDF ↗ |
| K183241 | BrainScope TBI (Model: Ahead 400) | Brainscope Company, Inc. | 2019-02-19 | Traditional | PDF ↗ |
| K181785 | Modified BrainScope One | Brainscope Company, Inc. | 2018-12-19 | Traditional | PDF ↗ |
| K181179 | BrainScope One | Brainscope Company, Inc. | 2018-05-18 | Special | PDF ↗ |
| K161068 | Ahead 300 | Brainscope Company, Inc. | 2016-09-22 | Traditional | PDF ↗ |
| K143643 | Brainscope Ahead 200 | Brainscope Company, Inc. | 2015-05-15 | Traditional | PDF ↗ |
| DEN140025 | BrainScope Ahead 100 | Brainscope Company, Inc. | 2014-11-17 | Direct | — |
Product code PIW · Class II · Neurology. Data: openFDA.