The following data is part of a premarket notification filed by Brainscope Company, Inc. with the FDA for Brainscope Ahead 200.
| Device ID | K143643 |
| 510k Number | K143643 |
| Device Name: | Brainscope Ahead 200 |
| Classification | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Applicant | BRAINSCOPE COMPANY, INC. 4350 EAST-WEST HIGHWAY SUITE 1050 Bethesda, MD 20814 |
| Contact | Michael E Singer |
| Correspondent | Michael E Singer BRAINSCOPE COMPANY, INC. 4350 EAST-WEST HIGHWAY SUITE 1050 Bethesda, MD 20814 |
| Product Code | PIW |
| CFR Regulation Number | 882.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-22 |
| Decision Date | 2015-05-15 |
| Summary: | summary |