BrainScope One— 510(k) K181179
Substantially EquivalentBrainscope Company, Inc.
FDA 510(k) clearance K181179 for BrainScope One, Substantially Equivalent on 2018-05-18. Applicant: Brainscope Company, Inc.. Device class: 2.
Clearance details
- Applicant
- Brainscope Company, Inc.
- Product code
- Code PIW
- Device class
- Class 2
- Regulation
- 21 CFR 882.1450
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bethesda, MD, US
Recent devices under product code PIW
view allMore clearances from Brainscope Company, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.