510(k) DEN140025
- Device
- BrainScope Ahead 100
- Applicant
- Brainscope Company, Inc.
- 510(k) number
- DEN140025
- Product code
- PIW
- Decision
- Unknown (DENG)
- Decision date
- 2014-11-17
- Date received
- 2014-08-20
- Regulation
- 882.1450
- Classification name
- Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
- Expedited review
- Y
Applicant Contact#
- Contact
- Michael E. Singer
- Address
- 4350 East-West Hwy., Suite 1050 Bethesda MD US 20814 20814
FDA Registration Numbers#
- 1287329
- 3018238599
- 3008660657
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PIW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243426 | Nurochek-Pro System | Headsafe Mfg Pty, Ltd. | 2025-03-27 |
| K231914 | Nurochek-II System | Headsafe Mfg Pty, Ltd. | 2023-12-27 |
| K190815 | BrainScope TBI | Brainscope Company, Inc. | 2019-09-11 |
| K183241 | BrainScope TBI (Model: Ahead 400) | Brainscope Company, Inc. | 2019-02-19 |
| K181785 | Modified BrainScope One | Brainscope Company, Inc. | 2018-12-19 |
| K181179 | BrainScope One | Brainscope Company, Inc. | 2018-05-18 |
| K161068 | Ahead 300 | Brainscope Company, Inc. | 2016-09-22 |
| K143643 | Brainscope Ahead 200 | Brainscope Company, Inc. | 2015-05-15 |