The following data is part of a premarket notification filed by Brainscope Company Inc with the FDA for Ahead 300.
| Device ID | K161068 |
| 510k Number | K161068 |
| Device Name: | Ahead 300 |
| Classification | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Applicant | BRAINSCOPE COMPANY INC 4350 East West Highway Suite 1050 Bethesda, MD 20814 |
| Contact | Michael Singer |
| Correspondent | Michael Singer BRAINSCOPE COMPANY INC 4350 East West Highway Suite 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 | 2016-04-15 |
| Decision Date | 2016-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852745007130 | K161068 | 000 |
| 00852745007079 | K161068 | 000 |
| 00852745007048 | K161068 | 000 |
| 00852745007024 | K161068 | 000 |
| 00852745007109 | K161068 | 000 |
| 00852745007260 | K161068 | 000 |