The following data is part of a premarket notification filed by Brainscope Company Inc. with the FDA for Modified Brainscope One.
| Device ID | K181785 |
| 510k Number | K181785 |
| Device Name: | Modified BrainScope One |
| Classification | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Applicant | BrainScope Company Inc. 4350 East West Hwy, Ste 1050 Bethesda, MD 20814 |
| Contact | Michael E Singer |
| Correspondent | Michael E Singer BrainScope Company Inc. 4350 East West Hwy, Ste 1050 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 | 2018-07-03 |
| Decision Date | 2018-12-19 |
| Summary: | summary |