The following data is part of a premarket notification filed by Brainscope Company Inc. with the FDA for Brainscope Tbi (model: Ahead 400).
Device ID | K183241 |
510k Number | K183241 |
Device Name: | BrainScope TBI (Model: Ahead 400) |
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 | 2018-11-21 |
Decision Date | 2019-02-19 |
Summary: | summary |