Data / Medical devices / United States / Brainscope
Brainscope: FDA-registered device maker in Rockville, MD, United States, 3 510(k) clearances
Brainscope is registered with the FDA (registration 3008660657) in Rockville, MD, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 11, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008660657
- Address
- 7648 Standish Place, Rockville, MD, United States, 20855
- Owner or operator
- BrainScope Company, Inc. (10039715)
- Roles
- Manufacturer
- First device listed
- February 15, 2017
- Registered through
- 2027
- Brand names listed
- Ahead® 300, BrainScope One, BrainScope One (Model: Ahead 500)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid | PIW | 2 | Manufacturer | accessdata.fda.gov |
| Computerized Cognitive Assessment Aid | PKQ | 2 | Manufacturer | accessdata.fda.gov |
| Normalizing Quantitative Electroencephalograph Software | OLU | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2019 | K190815 | BrainScope TBI | PIW | Substantially Equivalent | Brainscope Company, Inc. | accessdata.fda.gov |
| May 18, 2018 | K181179 | BrainScope One | PIW | Substantially Equivalent | Brainscope Company, Inc. | accessdata.fda.gov |
| September 22, 2016 | K161068 | Ahead 300 | PIW | Substantially Equivalent | Brainscope Company, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Normalizing Quantitative Electroencephalograph Software
- All makers of Computerized Cognitive Assessment Aid
Updated September 11, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.