510(k) K190815
- Device
- BrainScope TBI
- Applicant
- BrainScope Company, Inc.
- 510(k) number
- K190815
- Product code
- PIW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-09-11
- Date received
- 2019-03-29
- Regulation
- 882.1450
- Classification name
- Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Singer
- Address
- 4330 E. W. Hwy., Suite #1000 Bethesda MD US 20814 20814
FDA Registration Numbers#
- 3018238599
- 3008660657
- 1287329
Source Documents#
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 |
| 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 |
| DEN140025 | BrainScope Ahead 100 | Brainscope Company, Inc. | 2014-11-17 |
Legacy Summary#
summary
FDA Review#
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