The following data is part of a premarket notification filed by Brainscope Company, Inc. with the FDA for Brainscope Tbi.
| Device ID | K190815 |
| 510k Number | K190815 |
| Device Name: | BrainScope TBI |
| Classification | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Applicant | BrainScope Company, Inc. 4330 East West Highway, Suite #1000 Bethesda, MD 20814 |
| Contact | Michael Singer |
| Correspondent | Michael Singer BrainScope Company, Inc. 4330 East West Highway, Suite #1000 Bethesda, MD 20814 |
| Product Code | PIW |
| Subsequent Product Code | OLU |
| Subsequent Product Code | PKQ |
| CFR Regulation Number | 882.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-29 |
| Decision Date | 2019-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852745007239 | K190815 | 000 |
| 00852745007284 | K190815 | 000 |